YaoGeJu

Public drug landscapesDrug landscape

Loratadine Tablets

As of 13 November 2026, for Loratadine Tablets, 5 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 12 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as CLARITIN (NDA 019658, BAYER HEALTHCARE LLC).

Last 90 days: Accepted: 1 applicationNo longer listed under review: 1 application

Current coverage may be incomplete

Follow for free
Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 5 of 6 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
CLARITIN BAYER HEALTHCARE LLC NDA 019658 · Product no. 002 TABLET ORAL HUMAN OTC DRUG 2002/11/27
CLARITIN HIVES RELIEF BAYER HEALTHCARE LLC NDA 019658 · Product no. 003 TABLET ORAL HUMAN OTC DRUG 2003/11/19

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
CLARITIN BAYER HEALTHCARE LLC NDA 020641 · Product no. 002 SYRUP ORAL HUMAN OTC DRUG 2002/11/27
CLARITIN REDITABS BAYER HEALTHCARE LLC NDA 020704 · Product no. 002 TABLET, ORALLY DISINTEGRATING ORAL HUMAN OTC DRUG 2002/11/27
ALAVERT FOUNDATION CONSUMER BRANDS LLC NDA 021375 · Product no. 001 TABLET, ORALLY DISINTEGRATING ORAL HUMAN OTC DRUG 2002/12/19
CLARITIN HIVES RELIEF REDITAB BAYER HEALTHCARE LLC NDA 020704 · Product no. 003 TABLET, ORALLY DISINTEGRATING ORAL HUMAN OTC DRUG 2003/11/19
CLARITIN REDITABS BAYER HEALTHCARE LLC NDA 021993 · Product no. 001 TABLET, ORALLY DISINTEGRATING ORAL HUMAN OTC DRUG 2006/12/12
CLARITIN BAYER HEALTHCARE LLC NDA 021952 · Product no. 001 CAPSULE ORAL HUMAN OTC DRUG 2008/06/16
CLARITIN BAYER HEALTHCARE LLC NDA 021891 · Product no. 002 TABLET, CHEWABLE ORAL HUMAN OTC DRUG 2018/11/21
CLARITIN HIVES RELIEF BAYER HEALTHCARE LLC NDA 020641 · Product no. 003 SYRUP ORAL DISCONTINUED 2003/11/19

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

Chemical-drug catalogue

Loaded records: 12 holders; 10 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanizedBeijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H200500392025/07/1810mgDrug that passed quality-and-efficacy consistency evaluationCDE
Kunming Ji Da Pharmaceutical Co., Ltd. romanizedKunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H200403932025/07/1810mgDrug that passed quality-and-efficacy consistency evaluationCDE
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanizedHainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H200407972025/03/0310mgDrug that passed quality-and-efficacy consistency evaluationCDE
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanizedJiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H200457772023/08/1610mgDrug that passed quality-and-efficacy consistency evaluationCDE
Bei Da Pharmaceuticals Co., Ltd. romanizedBei Da Pharmaceuticals Co., Ltd. romanized国药准字H200407842022/09/2910mgDrug that passed quality-and-efficacy consistency evaluationCDE
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanizedGuangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H200522142022/03/0310mgDrug that passed quality-and-efficacy consistency evaluationCDE
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanizedSan Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H200201742022/03/0310mgDrug that passed quality-and-efficacy consistency evaluationCDE
Jiangsu Huang He Pharma Co., Ltd. romanizedJiangsu Huang He Pharma Co., Ltd. romanized国药准字H200509532021/05/2110mgDrug that passed quality-and-efficacy consistency evaluationCDE
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanizedWan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H200604022020/06/1110mgDrug that passed quality-and-efficacy consistency evaluationCDE
Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanizedYang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized国药准字H200801342019/12/1610mgDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedBai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized国药准字H109704101996/12/1710mgOther drugCDE
Bayer SA-NVSchering-Plough Labo N.V.H201604241993/01/0310mgImported originator drugCDE

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

NHSA drug codes

Loaded records: 34 distinct approval numbers and 34 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H2005003910mgCategory AXR06AXL226A001010100198NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010100363NHSA
Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized国药准字H2003129910mgCategory AXR06AXL226A001010100523NHSA
Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized国药准字H1097041010mgCategory AXR06AXL226A001010100784NHSA
Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized国药准字H2008013410mgCategory AXR06AXL226A001010100841NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H2004078410mgCategory AXR06AXL226A001010100976NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010101243NHSA
Fei Sen You Si Ka Bi Hua Rui Pharmaceutical Co., Ltd. romanized国药准字H2004055710mgCategory AXR06AXL226A001010101415NHSA
Jiangsu Huang He Pharma Co., Ltd. romanized国药准字H2005095310mgCategory AXR06AXL226A001010101450NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010101467NHSA
Su Zhong Pharma Group Co., Ltd. romanized国药准字H2004101610mgCategory AXR06AXL226A001010101492NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010101510NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H2003111210mgCategory AXR06AXL226A001010101523NHSA
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H2004165910mgCategory AXR06AXL226A001010101583NHSA
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H2003000410mgCategory AXR06AXL226A001010101749NHSA
Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized国药准字H2003011210mgCategory AXR06AXL226A001010102031NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010102076NHSA
Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized国药准字H2005212010mgCategory AXR06AXL226A001010102264NHSA
Xian Yang Sen Pharmaceutical Co., Ltd. romanized国药准字H2007003010mgCategory AXR06AXL226A001010102529NHSA
Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized国药准字H2008010510mgCategory AXR06AXL226A001010102946NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010103036NHSA
Topfond Pharmaceutical Co., Ltd.国药准字H2006706610mgCategory AXR06AXL226A001010103098NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010103190NHSA
Qingdao Shuang Jing Pharma Co., Ltd. romanized国药准字H2004049810mgCategory AXR06AXL226A001010104052NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010104121NHSA
Shandong Tian Shun Pharma Co., Ltd. romanized国药准字H2005168810mgCategory AXR06AXL226A001010104174NHSA
Zhejiang Hong Sheng Pharma Co., Ltd. romanized国药准字H2005215710mgCategory AXR06AXL226A001010104645NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010104658NHSA
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H2004039310mgCategory AXR06AXL226A001010105589NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010105777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010105830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010105848NHSA
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H2005003910mgCategory AXR06AXL226A001010200198NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010200363NHSA
Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized国药准字H2003129910mgCategory AXR06AXL226A001010200523NHSA
Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized国药准字H1097041010mgCategory AXR06AXL226A001010200784NHSA
Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized国药准字H2008013410mgCategory AXR06AXL226A001010200841NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H2004078410mgCategory AXR06AXL226A001010200976NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010201243NHSA
Jiangsu Huang He Pharma Co., Ltd. romanized国药准字H2005095310mgCategory AXR06AXL226A001010201450NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010201467NHSA
Su Zhong Pharma Group Co., Ltd. romanized国药准字H2004101610mgCategory AXR06AXL226A001010201492NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010201510NHSA
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD国药准字H2003111210mgCategory AXR06AXL226A001010201523NHSA
Nanjing Sheng He Pharma Co., Ltd. romanized国药准字H2004165910mgCategory AXR06AXL226A001010201583NHSA
Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized国药准字H2003011210mgCategory AXR06AXL226A001010202031NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010202076NHSA
Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized国药准字H2005212010mgCategory AXR06AXL226A001010202264NHSA
Xian Lan Tai Pharma Co., Ltd. romanized国药准字H2005192710mgCategory AXR06AXL226A001010202498NHSA
Xian Yang Sen Pharmaceutical Co., Ltd. romanized国药准字H2007003010mgCategory AXR06AXL226A001010202529NHSA
Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized国药准字H2008010510mgCategory AXR06AXL226A001010202946NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010203036NHSA
Topfond Pharmaceutical Co., Ltd.国药准字H2006706610mgCategory AXR06AXL226A001010203098NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010203190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010204121NHSA
Shandong Tian Shun Pharma Co., Ltd. romanized国药准字H2005168810mgCategory AXR06AXL226A001010204174NHSA
Zhejiang Hong Sheng Pharma Co., Ltd. romanized国药准字H2005215710mgCategory AXR06AXL226A001010204645NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010204658NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001010204864NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010205777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010205830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010205848NHSA
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H2005003910mgCategory AXR06AXL226A001010300198NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010300363NHSA
Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized国药准字H2008013410mgCategory AXR06AXL226A001010300841NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H2004078410mgCategory AXR06AXL226A001010300976NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010301243NHSA
Jiangsu Huang He Pharma Co., Ltd. romanized国药准字H2005095310mgCategory AXR06AXL226A001010301450NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010301467NHSA
Su Zhong Pharma Group Co., Ltd. romanized国药准字H2004101610mgCategory AXR06AXL226A001010301492NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010301510NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010302076NHSA
Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized国药准字H2005212010mgCategory AXR06AXL226A001010302264NHSA
Xian Lan Tai Pharma Co., Ltd. romanized国药准字H2005192710mgCategory AXR06AXL226A001010302498NHSA
Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized国药准字H2008010510mgCategory AXR06AXL226A001010302946NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010303036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010303190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010304121NHSA
Shandong Tian Shun Pharma Co., Ltd. romanized国药准字H2005168810mgCategory AXR06AXL226A001010304174NHSA
Zhejiang Hong Sheng Pharma Co., Ltd. romanized国药准字H2005215710mgCategory AXR06AXL226A001010304645NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010304658NHSA
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H2004039310mgCategory AXR06AXL226A001010305589NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010305777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010305830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010305848NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010400363NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H2004078410mgCategory AXR06AXL226A001010400976NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010401243NHSA
Jiangsu Huang He Pharma Co., Ltd. romanized国药准字H2005095310mgCategory AXR06AXL226A001010401450NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010401467NHSA
Su Zhong Pharma Group Co., Ltd. romanized国药准字H2004101610mgCategory AXR06AXL226A001010401492NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010401510NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010402076NHSA
Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized国药准字H2005212010mgCategory AXR06AXL226A001010402264NHSA
Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized国药准字H2008010510mgCategory AXR06AXL226A001010402946NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010403036NHSA
Topfond Pharmaceutical Co., Ltd.国药准字H2006706610mgCategory AXR06AXL226A001010403098NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010403190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010404121NHSA
Zhejiang Hong Sheng Pharma Co., Ltd. romanized国药准字H2005215710mgCategory AXR06AXL226A001010404645NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010404658NHSA
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H2004039310mgCategory AXR06AXL226A001010405589NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010405777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010405830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010405848NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010500363NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010501243NHSA
Jiangsu Huang He Pharma Co., Ltd. romanized国药准字H2005095310mgCategory AXR06AXL226A001010501450NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010501467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010501510NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010502076NHSA
Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized国药准字H2008010510mgCategory AXR06AXL226A001010502946NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010503036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010503190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010504121NHSA
Zhejiang Hong Sheng Pharma Co., Ltd. romanized国药准字H2005215710mgCategory AXR06AXL226A001010504645NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010504658NHSA
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字H2004039310mgCategory AXR06AXL226A001010505589NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010505777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010505830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010505848NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010600363NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010601243NHSA
Jiangsu Huang He Pharma Co., Ltd. romanized国药准字H2005095310mgCategory AXR06AXL226A001010601450NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010601467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010601510NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010602076NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010603036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010603190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010604121NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010604658NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010605777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010605830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010605848NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010700363NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010701243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010701467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010701510NHSA
Chengdu Yong Kang Pharmaceutical Co., Ltd. romanized国药准字H2005161810mgCategory AXR06AXL226A001010702076NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010703036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010703190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010704121NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H2003021310mgCategory AXR06AXL226A001010704658NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010705777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010705830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010705848NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010800363NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010801243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010801467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010801510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010803036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010803190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010804121NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010805777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010805830NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001010805848NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001010900363NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001010901243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001010901467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001010901510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001010903036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001010903190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001010904121NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001010905777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001010905830NHSA
Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized国药准字H2005221410mgCategory AXR06AXL226A001011000363NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011001243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001011001467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001011001510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001011003036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011003190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001011004121NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001011005777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001011005830NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011101243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001011101467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001011101510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001011103036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011103190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001011104121NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001011105777NHSA
Hainan Xin Shi Tong Pharmaceutical Co., Ltd. romanized国药准字H2004188610mgCategory AXR06AXL226A001011105830NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011201243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001011201467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001011201510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001011203036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011203190NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001011204121NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001011205777NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011301243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001011301467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001011301510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001011303036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011303190NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001011305777NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011401243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001011401467NHSA
Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized国药准字H2004577710mgCategory AXR06AXL226A001011401510NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001011403036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011403190NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001011405777NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011501243NHSA
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.国药准字H2004075510mgCategory AXR06AXL226A001011501467NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001011503036NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011503190NHSA
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized国药准字H2004079710mgCategory AXR06AXL226A001011505777NHSA
Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized国药准字H2004139610mgCategory AXR06AXL226A001011601243NHSA
San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized国药准字H2002017410mgCategory AXR06AXL226A001011603190NHSA
Henan Jiu Shi Pharmaceutical Co., Ltd. romanized国药准字H2005000910mgCategory AXR06AXL226A001020103036NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001020104121NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020104864NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001020105848NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020204864NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001020205848NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020304864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020404864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020504864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020604864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020704864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020804864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001020904864NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001020905848NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001021005848NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001021104864NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001021105848NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001021304121NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001021404121NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001021504121NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001021604121NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001021704121NHSA
Shandong Liang Fu Pharmaceutical Co., Ltd. romanized国药准字H2005112510mgCategory AXR06AXL226A001021804121NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001030104864NHSA
Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H2006040210mgCategory AXR06AXL226A001030105848NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001030204864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001030304864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001031204864NHSA
Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized国药准字H2005023310mgCategory AXR06AXL226A001031304864NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 5 filings and 5 distinct first applicants.

Generic 2 · Supplement 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Vanguard Pharmaceutical Co., Ltd.CYHS2601192Generic2026/05/25Not stated by sourceCDE
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.CYHB2650121Supplement2026/05/18Not stated by sourceCDE
CISEN PHARMACEUTICAL CO., LTD.CYHS2602061Generic2026/08/20Not stated by sourceCDE
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHB2601519Supplement2026/08/10Not stated by sourceCDE
Shandong Liang Fu Pharmaceutical Co., Ltd. romanizedCYHB2650010Supplement2026/01/09Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Vanguard Pharmaceutical Co., Ltd.CYHS2601192Generic2026/05/25Not stated by sourceCDE
CISEN PHARMACEUTICAL CO., LTD.CYHS2602061Generic2026/08/20Not stated by sourceCDE
API registrations

Non-component matches: 34 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
氯雷他定 · No verified English nameTagoor Laboratories Private LimitedY20240001028IExact ingredient2024/12/09CDE
氯雷他定 · No verified English nameMorepen Laboratories LtdY20230000137AExact ingredient2025/03/14CDE
氯雷他定 · No verified English nameNanjing Yi Hua Pharma Co., Ltd. romanizedY20230000259AExact ingredient2024/09/02CDE
氯雷他定 · No verified English nameMatrix Pharmacorp Private LimitedY20190000502AExact ingredient2026/06/02CDE
氯雷他定 · No verified English nameVasudha Pharma Chem LimitedY20190009997AExact ingredient2026/07/30CDE
氯雷他定 · No verified English nameSchering-Plough EuropeY20190009311AExact ingredient—CDE
氯雷他定 · No verified English nameChangzhou Ya Bang Pharmaceutical Co., Ltd. romanizedY20190008725AExact ingredient2025/07/24CDE
氯雷他定 · No verified English nameSan Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanizedY20190008555AExact ingredient2024/11/01CDE
氯雷他定 · No verified English nameZhejiang Dong Ya Pharma Co., Ltd. romanizedY20190008454AExact ingredient2024/12/07CDE
氯雷他定 · No verified English nameHunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanizedY20190008305AExact ingredient2024/11/28CDE
氯雷他定 · No verified English nameShanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanizedY20190008269AExact ingredient2023/03/24CDE
氯雷他定 · No verified English nameNanjing Sheng He Pharma Co., Ltd. romanizedY20190008187AExact ingredient2026/05/18CDE
氯雷他定 · No verified English nameChengdu Ao Bang Pharma Co., Ltd. romanizedY20190008149AExact ingredient2025/12/26CDE
氯雷他定 · No verified English nameSichuan Wei Ao Pharmaceutical Co., Ltd. romanizedY20190008142AExact ingredient2025/10/10CDE
氯雷他定 · No verified English nameWan Te Pharmaceutical (Hainan) Co., Ltd. romanizedY20190008138AExact ingredient2025/09/16CDE
氯雷他定 · No verified English nameHunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY20190008134AExact ingredient2025/07/28CDE
氯雷他定 · No verified English nameZhuhai Bao Shui Qu Li Zhu He Cheng Pharmaceutical Co., Ltd. romanizedY20190008122AExact ingredient2024/11/21CDE
氯雷他定 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20190008097AExact ingredient2024/06/12CDE
氯雷他定 · No verified English nameHebei Yuan Sen Pharmaceutical Co., Ltd. romanizedY20190008088AExact ingredient2025/05/07CDE
氯雷他定 · No verified English nameShenzhen Hai Wang Pharma Co., Ltd. romanizedY20190008061AExact ingredient2024/12/27CDE
氯雷他定 · No verified English nameJiangsu Heng Rui Pharmaceuticals Co., Ltd. romanizedY20190008022AExact ingredient—CDE
氯雷他定 · No verified English nameGuo Yao Group Zhi Jun (Suzhou) Pharmaceutical Co., Ltd. romanizedY20190007939AExact ingredient—CDE
氯雷他定 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20190007867AExact ingredient2026/02/03CDE
氯雷他定 · No verified English nameKunming Ji Da Pharmaceutical Co., Ltd. romanizedY20190007865AExact ingredient2025/06/21CDE
氯雷他定 · No verified English nameShenzhen Xin Li Tai Pharma Co., Ltd. romanizedY20190007851AExact ingredient2024/09/12CDE
氯雷他定 · No verified English nameWan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanizedY20190007841AExact ingredient2024/09/28CDE
氯雷他定 · No verified English nameGuangdong Hua Run Shun Feng Pharma Co., Ltd. romanizedY20190007837AExact ingredient2024/08/15CDE
氯雷他定 · No verified English nameZhejiang Hai Zheng Pharma Co., Ltd. romanizedY20190007818AExact ingredient—CDE
氯雷他定 · No verified English nameHenan Jiu Shi Pharmaceutical Co., Ltd. romanizedY20190007802AExact ingredient2025/01/15CDE
氯雷他定 · No verified English nameShandong Luo Xin Pharma Group Heng Xin Pharma Co., Ltd. romanizedY20190007796AExact ingredient2025/02/20CDE
氯雷他定 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190007772AExact ingredient2025/03/07CDE
氯雷他定 · No verified English nameChongqing Xi Nan He Cheng Pharmaceutical Co., Ltd. romanizedY20190007758AExact ingredient—CDE
氯雷他定 · No verified English nameZhejiang Chang Ming Pharma Co., Ltd. romanizedY20190007728AExact ingredient—CDE
盐酸氯雷他定 · No verified English nameJinan Heng Ji Pharmaceutical Co., Ltd. romanizedY20190002301ASalt-normalized ingredient2025/05/13CDE
氯雷他定 · No verified English nameJiangsu Jing Ye Pharmaceutical Co., Ltd. romanizedY20170002304AExact ingredient2023/12/19CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/11/11No longer listed under review

    Huayi Pharmaceuticals (Anhui) Co., Ltd.

    CYHS2502486

    Fact date: 2026/11/11 · Site observation date: 2026/11/11

    Accepted: 2025/07/12

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/08/20Accepted

    CISEN PHARMACEUTICAL CO., LTD.

    CYHS2602061

    Fact date: 2026/08/20 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.

NMPA drug delivery notices
Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete

First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.

Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.

Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

Free follow

Follow changes to Loratadine Tablets

Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.

Confirmation links expire in 7 days. No digest is sent before confirmation; existing follows are not duplicated.

Sign in to choose products