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Sign in to subscribeAs of 13 November 2026, for Levocarnitine Oral Solution, 9 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as CARNITOR (NDA 019257, LEADIANT BIOSCIENCES INC).
Last 90 days: Accepted: 2 applicationsNo longer listed under review: 1 application
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: Oral Solution. 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 |
|---|---|---|---|---|---|---|
| CARNITOR | LEADIANT BIOSCIENCES INC | NDA 019257 · Product no. 001 | SOLUTION | ORAL | HUMAN PRESCRIPTION DRUG | 1986/04/10 |
| CARNITOR SF | LEADIANT BIOSCIENCES INC | NDA 019257 · Product no. 002 | SOLUTION | ORAL | HUMAN PRESCRIPTION DRUG | 2007/03/28 |
| CARNITOR | LEADIANT BIOSCIENCES INC | NDA 018948 · Product no. 002 | SOLUTION | ORAL | DISCONTINUED | 1988/04/27 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| CARNITOR | LEADIANT BIOSCIENCES INC | NDA 018948 · Product no. 001 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 1985/12/27 |
| CARNITOR | LEADIANT BIOSCIENCES INC | NDA 020182 · Product no. 001 | INJECTABLE | INJECTION | HUMAN PRESCRIPTION DRUG | 1992/12/16 |
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: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| ALFASIGMA S.p.A. | ALFASIGMA S.p.A. | H20171307 | 2013/06/26 | 10ml:1g | Imported originator drug | CDE |
| ALFASIGMA S.p.A. | ALFASIGMA S.p.A. | H20171308 | 2013/06/26 | 10ml:2g | 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: 37 distinct approval numbers and 32 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20255565 | 10ml:1g | Category B | XG04BXZ059X001010101012 | NHSA |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103448 | 10ml:1g | Category B | XG04BXZ059X001010101123 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H19990372 | 10ml:1g | Category B | XG04BXZ059X001010101162 | NHSA |
| Dong Yao Group Shenyang Shi De Pharma Co., Ltd. romanized | 国药准字H20253799 | 10ml:1g | Category B | XG04BXZ059X001010101317 | NHSA |
| Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | 国药准字H20000522 | 10ml:1g | Category B | XG04BXZ059X001010101376 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254530 | 10ml:1g | Category B | XG04BXZ059X001010102763 | NHSA |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20254544 | 10ml:1g | Category B | XG04BXZ059X001010103421 | NHSA |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20255544 | 10ml:1g | Category B | XG04BXZ059X001010103687 | NHSA |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | 国药准字H20264294 | 10ml:1g | Category B | XG04BXZ059X001010103804 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20123100 | 10ml:1g | Category B | XG04BXZ059X001010104145 | NHSA |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H20203109 | 10ml:1g | Category B | XG04BXZ059X001010104193 | NHSA |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H20244005 | 10ml:1g | Category B | XG04BXZ059X001010104610 | NHSA |
| Zhejiang Kai Run Pharma Co., Ltd. romanized | 国药准字H20223622 | 10ml:1g | Category B | XG04BXZ059X001010104649 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265285 | 10ml:1g | Category B | XG04BXZ059X001010104685 | NHSA |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263359 | 10ml:1g | Category B | XG04BXZ059X001010104918 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20173337 | 10ml:1g | Category B | XG04BXZ059X001010105001 | NHSA |
| Beijing Kang Zhen Bio Technology Co., Ltd. romanized | 国药准字H20249135 | 10ml:1g | Category B | XG04BXZ059X001010109198 | NHSA |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20254713 | 10ml:1g | Category B | XG04BXZ059X001010110029 | NHSA |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | 国药准字H20254950 | 10ml:1g | Category B | XG04BXZ059X001010110137 | NHSA |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | H20171061 | 10ml:1g | Category B | XG04BXZ059X001010178871 | NHSA |
| ALFASIGMA S.p.A. | H20171307 | 10ml:1g | Category B | XG04BXZ059X001010182194 | NHSA |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20193098 | 10ml:1g | Category B | XG04BXZ059X001010182209 | NHSA |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20265020 | 10ml∶1g | Category B | XG04BXZ059X001010182338 | NHSA |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H20244178 | 10ml:1g | Category B | XG04BXZ059X001010183337 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20254529 | 10ml:1g | Category B | XG04BXZ059X001010183595 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20265500 | 10ml:1g | Category B | XG04BXZ059X001010183611 | NHSA |
| Sichuan Jia Chuang Jing Tai Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233597 | 10ml:1g | Category B | XG04BXZ059X001010183919 | NHSA |
| Gu Ge Er Pharma (Hainan) Co., Ltd. romanized | 国药准字H20249189 | 10ml:1g | Category B | XG04BXZ059X001010184286 | NHSA |
| Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249495 | 10ml:1g | Category B | XG04BXZ059X001010184329 | NHSA |
| Hubei Xin Ze Fei Pharma Co., Ltd. romanized | 国药准字H20243026 | 10ml:1g | Category B | XG04BXZ059X001010184522 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20249009 | 10ml:1g | Category B | XG04BXZ059X001010185253 | NHSA |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H20264835 | 10ml∶1g | Category B | XG04BXZ059X001010186360 | NHSA |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103448 | 10ml:1g | Category B | XG04BXZ059X001010201123 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H19990372 | 10ml:1g | Category B | XG04BXZ059X001010201162 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254530 | 10ml:1g | Category B | XG04BXZ059X001010202763 | NHSA |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20254544 | 10ml:1g | Category B | XG04BXZ059X001010203421 | NHSA |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20255544 | 10ml:1g | Category B | XG04BXZ059X001010203687 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20123100 | 10ml:1g | Category B | XG04BXZ059X001010204145 | NHSA |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H20203109 | 10ml:1g | Category B | XG04BXZ059X001010204193 | NHSA |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H20244005 | 10ml:1g | Category B | XG04BXZ059X001010204610 | NHSA |
| Zhejiang Kai Run Pharma Co., Ltd. romanized | 国药准字H20223622 | 10ml:1g | Category B | XG04BXZ059X001010204649 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265285 | 10ml:1g | Category B | XG04BXZ059X001010204685 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20173337 | 10ml:1g | Category B | XG04BXZ059X001010205001 | NHSA |
| Beijing Kang Zhen Bio Technology Co., Ltd. romanized | 国药准字H20249135 | 10ml:1g | Category B | XG04BXZ059X001010209198 | NHSA |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20254713 | 10ml:1g | Category B | XG04BXZ059X001010210029 | NHSA |
| ALFASIGMA S.p.A. | H20171307 | 10ml:1g | Category B | XG04BXZ059X001010282194 | NHSA |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20193098 | 10ml:1g | Category B | XG04BXZ059X001010282209 | NHSA |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20265020 | 10ml∶1g | Category B | XG04BXZ059X001010282338 | NHSA |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H20244178 | 10ml:1g | Category B | XG04BXZ059X001010283337 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20254529 | 10ml:1g | Category B | XG04BXZ059X001010283595 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20265500 | 10ml:1g | Category B | XG04BXZ059X001010283611 | NHSA |
| Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249495 | 10ml:1g | Category B | XG04BXZ059X001010284329 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20249009 | 10ml:1g | Category B | XG04BXZ059X001010285253 | NHSA |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H20264835 | 10ml∶1g | Category B | XG04BXZ059X001010286360 | NHSA |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103448 | 10ml:1g | Category B | XG04BXZ059X001010301123 | NHSA |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20254544 | 10ml:1g | Category B | XG04BXZ059X001010303421 | NHSA |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20255544 | 10ml:1g | Category B | XG04BXZ059X001010303687 | NHSA |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H20203109 | 10ml:1g | Category B | XG04BXZ059X001010304193 | NHSA |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H20244005 | 10ml:1g | Category B | XG04BXZ059X001010304610 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265285 | 10ml:1g | Category B | XG04BXZ059X001010304685 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20173337 | 10ml:1g | Category B | XG04BXZ059X001010305001 | NHSA |
| Beijing Kang Zhen Bio Technology Co., Ltd. romanized | 国药准字H20249135 | 10ml:1g | Category B | XG04BXZ059X001010309198 | NHSA |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20254713 | 10ml:1g | Category B | XG04BXZ059X001010310029 | NHSA |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20193098 | 10ml:1g | Category B | XG04BXZ059X001010382209 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20254529 | 10ml:1g | Category B | XG04BXZ059X001010383595 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20265500 | 10ml:1g | Category B | XG04BXZ059X001010383611 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20249009 | 10ml:1g | Category B | XG04BXZ059X001010385253 | NHSA |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H20264835 | 10ml∶1g | Category B | XG04BXZ059X001010386360 | NHSA |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103448 | 10ml:1g | Category B | XG04BXZ059X001010401123 | NHSA |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20254544 | 10ml:1g | Category B | XG04BXZ059X001010403421 | NHSA |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20255544 | 10ml:1g | Category B | XG04BXZ059X001010403687 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20173337 | 10ml:1g | Category B | XG04BXZ059X001010405001 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20254529 | 10ml:1g | Category B | XG04BXZ059X001010483595 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20265500 | 10ml:1g | Category B | XG04BXZ059X001010483611 | NHSA |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H20264835 | 10ml∶1g | Category B | XG04BXZ059X001010486360 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20254529 | 10ml:1g | Category B | XG04BXZ059X001010583595 | NHSA |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H20264835 | 10ml∶1g | Category B | XG04BXZ059X001010586360 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20254529 | 10ml:1g | Category B | XG04BXZ059X001010683595 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H19990372 | 10ml:1g | Category B | XG04BXZ059X001020101162 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20123100 | 10ml:1g | Category B | XG04BXZ059X001020104145 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265284 | 10ml:2g | Category B | XG04BXZ059X001020104685 | NHSA |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20254714 | 10ml:2g | Category B | XG04BXZ059X001020110029 | NHSA |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | H20171058 | 10ml:2g | Category B | XG04BXZ059X001020178871 | NHSA |
| ALFASIGMA S.p.A. | 国药准字HJ20171308 | 10ml: 2g | Category B | XG04BXZ059X001020182194 | NHSA |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H20244179 | 10ml:2g | Category B | XG04BXZ059X001020183337 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H19990372 | 10ml:1g | Category B | XG04BXZ059X001020201162 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265284 | 10ml:2g | Category B | XG04BXZ059X001020204685 | NHSA |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20254714 | 10ml:2g | Category B | XG04BXZ059X001020210029 | NHSA |
| ALFASIGMA S.p.A. | 国药准字HJ20171308 | 10ml: 2g | Category B | XG04BXZ059X001020282194 | NHSA |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H20244179 | 10ml:2g | Category B | XG04BXZ059X001020283337 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265284 | 10ml:2g | Category B | XG04BXZ059X001020304685 | NHSA |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H20244179 | 10ml:2g | Category B | XG04BXZ059X001020383337 | 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: 9 filings and 8 distinct first applicants.
Generic 9
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yunnan Hai Feng Pharma Co., Ltd. romanized | CYHS2602332 | Generic | 2026/09/18 | Not stated by source | CDE |
| Jin Zhou Ben Tian Pharma Co., Ltd. romanized | CYHS2504414 | Generic | 2025/12/26 | Not stated by source | CDE |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2504325 | Generic | 2025/12/19 | Not stated by source | CDE |
| Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | CYHS2503485 | Generic | 2025/09/22 | Not stated by source | CDE |
| Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | CYHS2503484 | Generic | 2025/09/22 | Not stated by source | CDE |
| Shandong Kang Lin Pharmaceuticals Co., Ltd. romanized; Shandong Yi Kang Pharma Co., Ltd. romanized | CYHS2503224 | Generic | 2025/09/02 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2502276 | Generic | 2025/06/26 | Not stated by source | CDE |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2502061 | Generic | 2025/06/11 | Not stated by source | CDE |
| Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CYHS2602672 | Generic | 2026/11/02 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yunnan Hai Feng Pharma Co., Ltd. romanized | CYHS2602332 | Generic | 2026/09/18 | Not stated by source | CDE |
| Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CYHS2602672 | Generic | 2026/11/02 | Not stated by source | CDE |
Non-component matches: 11 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 左卡尼汀 · No verified English name | Jilin Sheng Si He Pharma Technology Co., Ltd. romanized | Y20230001159 | A | Exact ingredient | 2025/07/21 | CDE |
| 左卡尼汀 · No verified English name | Zhejiang Zhu Zi Pharmaceutical Co., Ltd. romanized | Y20230001188 | A | Exact ingredient | 2026/07/28 | CDE |
| 左卡尼汀 · No verified English name | Shandong Qidu Pharmaceutical Co., Ltd. | Y20230001051 | A | Exact ingredient | 2025/08/19 | CDE |
| 左卡尼汀 · No verified English name | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20230000689 | A | Exact ingredient | 2025/04/16 | CDE |
| 左卡尼汀 · No verified English name | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | Y20220001204 | A | Exact ingredient | 2025/02/28 | CDE |
| 左卡尼汀 · No verified English name | Hong Bo Zhi Yuan (Kai Yuan) Pharma Co., Ltd. romanized | Y20210001266 | A | Exact ingredient | 2025/09/04 | CDE |
| 左卡尼汀 · No verified English name | Shanghai Bo Teng Zhi Tuo Pharmaceuticals Technology Co., Ltd. romanized | Y20210000770 | A | Exact ingredient | 2024/11/12 | CDE |
| 左卡尼汀 · No verified English name | Cheng Da Pharma Co., Ltd. romanized | Y20200000014 | A | Exact ingredient | 2023/05/24 | CDE |
| 左卡尼汀 · No verified English name | Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | Y20190003752 | A | Exact ingredient | 2026/10/09 | CDE |
| 左卡尼汀 · No verified English name | Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20190003163 | A | Exact ingredient | 2024/04/24 | CDE |
| 左卡尼汀 · No verified English name | Shandong Qidu Pharmaceutical Co., Ltd. | Y20170001602 | A | Exact ingredient | 2025/08/23 | CDE |
| 左卡尼汀 · No verified English name | Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | Y20170000014 | A | Exact ingredient | 2023/12/27 | 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.
CYHS2602672
Fact date: 2026/11/02 · Site observation date: 2026/11/03
View source ↗CYHS2501487
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/04/19
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2602332
Fact date: 2026/09/18 · 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.
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