Monthly
US$200
Billed every month
Sign in to subscribeAs of 13 November 2026, for Escitalopram Oxalate Tablets, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 18 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as LEXAPRO (NDA 021323, ABBVIE INC).
Last 90 days: Accepted: 4 applications
Current coverage may be incomplete
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 2 of 2 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.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| LEXAPRO | ABBVIE INC | NDA 021323 · Product no. 001, 002, 003 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2002/08/14 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| ESCITALOPRAM | ALMATICA PHARMA LLC | NDA 219130 · Product no. 001 | CAPSULE | ORAL | HUMAN PRESCRIPTION DRUG | 2025/08/29 |
| LEXAPRO | ABBVIE INC | NDA 021365 · Product no. 001 | SOLUTION | ORAL | DISCONTINUED | 2002/11/27 |
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.
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.
Loaded records: 18 holders; 5 in the quality-and-efficacy consistency-evaluation category, and 12 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | Shenyang Fu Ning Pharma Co., Ltd. romanized | 国药准字H20264751 | 2026/06/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20244517 | 2024/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20244518 | 2024/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20243682 | 2024/05/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593 | 2023/12/05 | See source | Not stated by source | CDE |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592 | 2023/12/05 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234063 | 2023/08/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234062 | 2023/08/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | Zhejiang Jiang Bei Pharma Co., Ltd. romanized | 国药准字H20233260 | 2023/03/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | Zhejiang Jiang Bei Pharma Co., Ltd. romanized | 国药准字H20233261 | 2023/03/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609 | 2022/08/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607 | 2022/08/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608 | 2022/08/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Lek Pharmaceuticals d.d. | Sandoz Private Limited | 国药准字HJ20220003 | 2022/01/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Yuan Pharma Co., Ltd. romanized | Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474 | 2021/06/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Yuan Pharma Co., Ltd. romanized | Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213475 | 2021/06/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Yuan Pharma Co., Ltd. romanized | Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473 | 2021/06/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 国药准字H20130105 | 2021/04/20 | 5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 国药准字H20130106 | 2021/04/20 | 10mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20213259 | 2021/04/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20213260 | 2021/04/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20213258 | 2021/04/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20213257 | 2021/04/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20213193 | 2021/03/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108 | 2020/09/25 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142 | 2020/09/04 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140109 | 2020/01/20 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308 | 2019/11/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300 | 2019/11/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | 2018/09/26 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | 2018/09/26 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548 | 2018/09/26 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391 | 2018/05/14 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788 | 2018/02/07 | 10mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| H. Lundbeck A/S | H.Lundbeck A/S | H20140121 | 2009/04/16 | 20mg | Imported originator drug | CDE |
| H. Lundbeck A/S | H.Lundbeck A/S | H20150161 | 2005/08/31 | 5mg | Imported originator drug | CDE |
| H. Lundbeck A/S | H.Lundbeck A/S | H20150163 | 2005/08/31 | 10mg | Imported originator drug | CDE |
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.
Loaded records: 35 distinct approval numbers and 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592 | See source | Category A | XN06ABA225A001010102016 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142 | See source | Category A | XN06ABA225A001010102180 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788 | See source | Category A | XN06ABA225A001010102292 | NHSA |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140109 | See source | Category A | XN06ABA225A001010103454 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001010104111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607 | See source | Category A | XN06ABA225A001010104152 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682 | See source | Category A | XN06ABA225A001010104187 | NHSA |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193 | See source | Category A | XN06ABA225A001010104561 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473 | See source | Category A | XN06ABA225A001010104646 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308 | See source | Category A | XN06ABA225A001010104647 | NHSA |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H20130106 | 10mg | Category A | XN06ABA225A001010104656 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391 | See source | Category A | XN06ABA225A001010104917 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213257 | See source | Category A | XN06ABA225A001010106988 | NHSA |
| H. Lundbeck A/S | 国药准字HJ20150163 | See source | Category A | XN06ABA225A001010178996 | NHSA |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003 | See source | Category A | XN06ABA225A001010179428 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234062 | See source | Category A | XN06ABA225A001010180086 | NHSA |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20244517 | See source | Category A | XN06ABA225A001010181400 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260 | See source | Category A | XN06ABA225A001010183254 | NHSA |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20264751 | See source | Category A | XN06ABA225A001010183285 | NHSA |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660 | See source | Category A | XN06ABA225A001010184621 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592 | See source | Category A | XN06ABA225A001010202016 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142 | See source | Category A | XN06ABA225A001010202180 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788 | See source | Category A | XN06ABA225A001010202292 | NHSA |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140109 | See source | Category A | XN06ABA225A001010203454 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001010204111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607 | See source | Category A | XN06ABA225A001010204152 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682 | See source | Category A | XN06ABA225A001010204187 | NHSA |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193 | See source | Category A | XN06ABA225A001010204561 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473 | See source | Category A | XN06ABA225A001010204646 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308 | See source | Category A | XN06ABA225A001010204647 | NHSA |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H20130106 | 10mg | Category A | XN06ABA225A001010204656 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391 | See source | Category A | XN06ABA225A001010204917 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213257 | See source | Category A | XN06ABA225A001010206988 | NHSA |
| H. Lundbeck A/S | 国药准字HJ20150163 | See source | Category A | XN06ABA225A001010278996 | NHSA |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003 | See source | Category A | XN06ABA225A001010279428 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260 | See source | Category A | XN06ABA225A001010283254 | NHSA |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660 | See source | Category A | XN06ABA225A001010284621 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592 | See source | Category A | XN06ABA225A001010302016 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142 | See source | Category A | XN06ABA225A001010302180 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788 | See source | Category A | XN06ABA225A001010302292 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001010304111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607 | See source | Category A | XN06ABA225A001010304152 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682 | See source | Category A | XN06ABA225A001010304187 | NHSA |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193 | See source | Category A | XN06ABA225A001010304561 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473 | See source | Category A | XN06ABA225A001010304646 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308 | See source | Category A | XN06ABA225A001010304647 | NHSA |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H20130106 | 10mg | Category A | XN06ABA225A001010304656 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391 | See source | Category A | XN06ABA225A001010304917 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260 | See source | Category A | XN06ABA225A001010383254 | NHSA |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660 | See source | Category A | XN06ABA225A001010384621 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592 | See source | Category A | XN06ABA225A001010402016 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142 | See source | Category A | XN06ABA225A001010402180 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788 | See source | Category A | XN06ABA225A001010402292 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001010404111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607 | See source | Category A | XN06ABA225A001010404152 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308 | See source | Category A | XN06ABA225A001010404647 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391 | See source | Category A | XN06ABA225A001010404917 | NHSA |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660 | See source | Category A | XN06ABA225A001010484621 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001010504111 | NHSA |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660 | See source | Category A | XN06ABA225A001010584621 | NHSA |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660 | See source | Category A | XN06ABA225A001010684621 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593 | See source | Category A | XN06ABA225A001020102016 | NHSA |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108 | See source | Category A | XN06ABA225A001020103454 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548 | See source | Category A | XN06ABA225A001020104111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608 | See source | Category A | XN06ABA225A001020104152 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474 | See source | Category A | XN06ABA225A001020104646 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300 | See source | Category A | XN06ABA225A001020104647 | NHSA |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H20130105 | 5mg | Category A | XN06ABA225A001020104656 | NHSA |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213258 | See source | Category A | XN06ABA225A001020106988 | NHSA |
| H.Lundbeck A/S | H20150161 | See source | Category A | XN06ABA225A001020178996 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234063 | See source | Category A | XN06ABA225A001020180086 | NHSA |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20244518 | See source | Category A | XN06ABA225A001020181400 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261 | See source | Category A | XN06ABA225A001020183254 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593 | See source | Category A | XN06ABA225A001020202016 | NHSA |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108 | See source | Category A | XN06ABA225A001020203454 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548 | See source | Category A | XN06ABA225A001020204111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608 | See source | Category A | XN06ABA225A001020204152 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474 | See source | Category A | XN06ABA225A001020204646 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300 | See source | Category A | XN06ABA225A001020204647 | NHSA |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H20130105 | 5mg | Category A | XN06ABA225A001020204656 | NHSA |
| H.Lundbeck A/S | H20150161 | See source | Category A | XN06ABA225A001020278996 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261 | See source | Category A | XN06ABA225A001020283254 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593 | See source | Category A | XN06ABA225A001020302016 | NHSA |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108 | See source | Category A | XN06ABA225A001020303454 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548 | See source | Category A | XN06ABA225A001020304111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608 | See source | Category A | XN06ABA225A001020304152 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474 | See source | Category A | XN06ABA225A001020304646 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300 | See source | Category A | XN06ABA225A001020304647 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261 | See source | Category A | XN06ABA225A001020383254 | NHSA |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593 | See source | Category A | XN06ABA225A001020402016 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608 | See source | Category A | XN06ABA225A001020404152 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030104111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609 | See source | Category A | XN06ABA225A001030104152 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20213475 | See source | Category A | XN06ABA225A001030104646 | NHSA |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H20130106 | 10mg | Category A | XN06ABA225A001030104656 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030204111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609 | See source | Category A | XN06ABA225A001030204152 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20213475 | See source | Category A | XN06ABA225A001030204646 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030304111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609 | See source | Category A | XN06ABA225A001030304152 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030404111 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609 | See source | Category A | XN06ABA225A001030404152 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030504111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030604111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001030704111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001040104111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001050104111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001050204111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327 | See source | Category A | XN06ABA225A001050304111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548 | See source | Category A | XN06ABA225A001060104111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548 | See source | Category A | XN06ABA225A001060204111 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599 | See source | Category A | XN06ABA225A001070104111 | NHSA |
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.
Loaded records: 6 filings and 3 distinct first applicants.
Generic 4 · Import 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602144 | Generic | 2026/08/27 | Not stated by source | CDE |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602143 | Generic | 2026/08/27 | Not stated by source | CDE |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602037 | Generic | 2026/08/18 | Not stated by source | CDE |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602036 | Generic | 2026/08/18 | Not stated by source | CDE |
| Maxmind Pharmaceutical S.L.; Macleods Pharmaceuticals Ltd.; Maxmind Biotechnology (Hainan) Co. Ltd. | JYHS2400060 | Import | 2024/12/05 | Not stated by source | CDE |
| Maxmind Pharmaceutical S.L.; Macleods Pharmaceuticals Ltd.; Maxmind Biotechnology (Hainan) Co. Ltd. | JYHS2400059 | Import | 2024/12/05 | Not stated by source | CDE |
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602144 | Generic | 2026/08/27 | Not stated by source | CDE |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602143 | Generic | 2026/08/27 | Not stated by source | CDE |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602037 | Generic | 2026/08/18 | Not stated by source | CDE |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602036 | Generic | 2026/08/18 | Not stated by source | CDE |
Non-component matches: 16 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 草酸艾司西酞普兰 · No verified English name | Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized | Y20260000777 | I | Exact ingredient | 2026/09/10 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20260000275 | I | Exact ingredient | 2026/04/29 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Virupaksha Organics Limited | Y20240000675 | A | Exact ingredient | 2026/04/21 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Hetero Labs Limited | Y20210001164 | A | Exact ingredient | 2024/12/29 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | Y20200000363 | I | Exact ingredient | 2020/05/15 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Olon S.p.A. | Y20190021297 | A | Exact ingredient | 2022/10/27 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Shandong Rui Shun Pharma Co., Ltd. romanized | Y20190009855 | A | Exact ingredient | 2024/01/17 | CDE |
| 草酸艾司西酞普兰 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190009839 | A | Exact ingredient | 2026/05/20 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20190008922 | A | Exact ingredient | 2024/07/26 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Shandong An Xin Pharmaceutical Co., Ltd. romanized | Y20190008896 | A | Exact ingredient | 2024/04/30 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Zhejiang Hai Sen Pharma Co., Ltd. romanized | Y20190007282 | A | Exact ingredient | 2023/08/16 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Wuxi Ji Da Pharmaceutical Co., Ltd. romanized | Y20190006965 | A | Exact ingredient | 2023/03/24 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Hunan Dong Ting Pharma Co., Ltd. romanized | Y20190001441 | A | Exact ingredient | 2024/10/18 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | Y20190001382 | A | Exact ingredient | 2025/08/09 | CDE |
| 草酸艾司西酞普兰 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20180001104 | A | Exact ingredient | 2026/05/20 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Shandong Rui Shun Pharma Co., Ltd. romanized | Y20170001891 | A | Exact ingredient | 2024/09/26 | CDE |
| 草酸艾司西酞普兰 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170001449 | A | Exact ingredient | 2024/02/08 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Shanghai Shyndec Pharmaceutical Co., Ltd. | Y20170001293 | A | Exact ingredient | 2024/01/18 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Rui Yang Pharmaceutical Co., Ltd. romanized | Y20170001283 | A | Exact ingredient | 2025/01/03 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20170000762 | A | Exact ingredient | 2023/08/10 | CDE |
| 草酸艾司西酞普兰 · No verified English name | Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | Y20170000654 | A | Exact ingredient | 2023/03/24 | CDE |
| 草酸艾司西酞普兰 · No verified English name | CISEN PHARMACEUTICAL CO., LTD. | Y20170000637 | I | Exact ingredient | — | CDE |
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.
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.
CYHS2602144
Fact date: 2026/08/27 · Site observation date: 2026/10/22
View source ↗CYHS2602143
Fact date: 2026/08/27 · Site observation date: 2026/10/22
View source ↗CYHS2602037
Fact date: 2026/08/18 · Site observation date: 2026/10/22
View source ↗CYHS2602036
Fact date: 2026/08/18 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
Sign in to subscribeUS$540
Billed every three months
US$180 per month
Sign in to subscribeUS$1,920
Billed every year
US$160 per month
Sign in to subscribeSeparate one-time purchase
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy