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Sign in to subscribeMemantine Hydrochloride Tablets
As of 13 November 2026, for Memantine Hydrochloride Tablets, 2 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 29 holders.
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
Current coverage may be incomplete
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 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.
Same dosage form
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| NAMENDA | ABBVIE INC | NDA 021487 · Product no. 001, 002 | TABLET | ORAL | DISCONTINUED | 2003/10/16 |
Other dosage forms of the same ingredient
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| NAMENDA | ALLERGAN SALES LLC | NDA 021627 · Product no. 001 | SOLUTION | ORAL | DISCONTINUED | 2005/04/18 |
| NAMENDA XR | ABBVIE INC | NDA 022525 · Product no. 001, 002, 003, 004 | CAPSULE, EXTENDED RELEASE | ORAL | DISCONTINUED | 2010/06/21 |
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.
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.
Catalogue holders29View records ↓
Under-review filings2View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers34View records ↓
API companies with A status37View records ↓
Chemical-drug catalogue
Loaded records: 29 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 26 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 |
|---|---|---|---|---|---|---|
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256103 | 2025/12/03 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Shang Rui Biopharmaceuticals Co., Ltd. romanized | Chengdu Tong De Pharma Co., Ltd. romanized | 国药准字H20255741 | 2025/10/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H20255692 | 2025/10/14 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 国药准字H20249194 | 2024/10/29 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Lin Heng Pharmaceutical Co., Ltd. romanized | Hainan Lin Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20244956 | 2024/09/19 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shaanxi Tian Di Ren He Pharma Co., Ltd. romanized | Yin Gu Pharmaceutical Co., Ltd. romanized | 国药准字H20244658 | 2024/08/20 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shaanxi Tian Di Ren He Pharma Co., Ltd. romanized | Yin Gu Pharmaceutical Co., Ltd. romanized | 国药准字H20244659 | 2024/08/20 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized | 国药准字H20243056 | 2024/01/16 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | 国药准字H20234004 | 2023/08/01 | 20mg | Not stated by source | CDE |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | 国药准字H20234003 | 2023/08/01 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20233592 | 2023/05/26 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20233545 | 2023/05/12 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H20233256 | 2023/03/07 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Dr. Reddy’s Laboratories Limited | Dr. Reddy’s Laboratories Limited | 国药准字HJ20220092 | 2022/11/22 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized | 国药准字H20223855 | 2022/11/15 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20223816 | 2022/11/08 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20223817 | 2022/11/08 | 15mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20223815 | 2022/11/08 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20223818 | 2022/11/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Hang Kang Pharma Co., Ltd. romanized | 国药准字H20223585 | 2022/08/10 | 10mg | 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H20223406 | 2022/06/16 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20213930 | 2021/12/08 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20213931 | 2021/12/08 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | 国药准字H20213729 | 2021/09/13 | 10mg | 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H20213657 | 2021/08/25 | 10mg | Not stated by source | CDE |
| Changchun Hai Yue Pharma Co., Ltd. romanized | Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20213596 | 2021/07/20 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H20130086 | 2021/05/21 | 10mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213119 | 2021/02/02 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Pu Luo Pharma Co., Ltd. romanized | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20213080 | 2021/01/30 | 10mg | Not stated by source | CDE |
| Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20203555 | 2020/11/04 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized | Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20203349 | 2020/07/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20203320 | 2020/07/16 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20203319 | 2020/07/16 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Hua Chen Pharmaceutical Co., Ltd. romanized | Anhui Hua Chen Pharmaceutical Co., Ltd. romanized | 国药准字H20203134 | 2020/03/31 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20203016 | 2020/01/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H20193268 | 2019/09/17 | 10mg | Generic approved under the new chemical-drug registration classification | 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.
NHSA drug codes
Loaded records: 34 distinct approval numbers and 29 companies.
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: 2 filings and 2 distinct first applicants.
Generic 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600773 | Generic | 2026/04/02 | Not stated by source | CDE |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2600142 | Generic | 2026/01/10 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600773 | Generic | 2026/04/02 | Not stated by source | CDE |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2600142 | Generic | 2026/01/10 | Not stated by source | CDE |
API registrations
Non-component matches: 37 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 盐酸美金刚 · No verified English name | OLON S.p.A. | Y20240001170 | A | Exact ingredient | 2026/09/01 | CDE |
| 盐酸美金刚 · No verified English name | Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20240000483 | A | Exact ingredient | 2025/12/18 | CDE |
| 盐酸美金刚 · No verified English name | Shenyang Tian Bang Pharma Co., Ltd. romanized | Y20230001221 | A | Exact ingredient | 2025/11/19 | CDE |
| 盐酸美金刚 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20230001198 | A | Exact ingredient | 2025/11/26 | CDE |
| 盐酸美金刚 · No verified English name | Anhui Pu Li Pharma Co., Ltd. romanized | Y20230000102 | A | Exact ingredient | 2024/09/10 | CDE |
| 盐酸美金刚 · No verified English name | Zhi En Bio Technology Co., Ltd. romanized | Y20220000214 | A | Exact ingredient | 2023/12/05 | CDE |
| 盐酸美金刚 · No verified English name | COHANCE LIFESCIENCES LIMITED | Y20210000513 | A | Exact ingredient | 2025/06/03 | CDE |
| 盐酸美金刚 · No verified English name | Shandong Hai You Fu Rui Da Pharmaceutical Co., Ltd. romanized | Y20210000467 | A | Exact ingredient | 2026/03/18 | CDE |
| 盐酸美金刚 · No verified English name | Anhui Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20210000550 | A | Exact ingredient | 2026/01/01 | CDE |
| 盐酸美金刚 · No verified English name | Unichem Laboratories Limited | Y20210000402 | A | Exact ingredient | 2023/08/11 | CDE |
| 盐酸美金刚 · No verified English name | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20200001047 | A | Exact ingredient | 2022/10/28 | CDE |
| 盐酸美金刚 · No verified English name | Zhejiang Shang Tai Biopharmaceutical Co., Ltd. romanized | Y20200001118 | A | Exact ingredient | 2026/09/17 | CDE |
| 盐酸美金刚 · No verified English name | Dr.Reddy's Laboratories Ltd. | Y20200000988 | A | Exact ingredient | 2023/05/01 | CDE |
| 盐酸美金刚 · No verified English name | Sichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanized | Y20200001003 | A | Exact ingredient | 2023/07/24 | CDE |
| 盐酸美金刚 · No verified English name | Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | Y20190021531 | A | Exact ingredient | 2023/07/28 | CDE |
| 盐酸美金刚 · No verified English name | Matrix Pharmacorp Private Limited | Y20190001079 | A | Exact ingredient | 2026/05/20 | CDE |
| 盐酸美金刚 · No verified English name | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | Y20190007101 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸美金刚 · No verified English name | Hunan Dong Ting Pharma Co., Ltd. romanized | Y20190006826 | A | Exact ingredient | — | CDE |
| 盐酸美金刚 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190006801 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸美金刚 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190000580 | A | Exact ingredient | 2026/06/12 | CDE |
| 盐酸美金刚 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20190000706 | A | Exact ingredient | 2025/06/25 | CDE |
| 盐酸美金刚 · No verified English name | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190000110 | A | Exact ingredient | 2025/07/29 | CDE |
| 盐酸美金刚 · No verified English name | UNION QUIMICO FARMACEUTICA, SA (UQUIFA) | Y20190000047 | I | Exact ingredient | 2019/03/13 | CDE |
| 盐酸美金刚 · No verified English name | MSN Pharmachem Private Limited | Y20180001481 | A | Exact ingredient | 2025/06/17 | CDE |
| 盐酸美金刚 · No verified English name | Anhui Hua Chen Pharmaceutical Co., Ltd. romanized | Y20180000939 | A | Exact ingredient | 2025/01/18 | CDE |
| 盐酸美金刚 · No verified English name | Shandong Luo Xin Pharma Group Heng Xin Pharma Co., Ltd. romanized | Y20170002157 | I | Exact ingredient | — | CDE |
| 盐酸美金刚 · No verified English name | Hetero Drugs Limited (Unit-IX) | Y20170001630 | A | Exact ingredient | 2023/02/17 | CDE |
| 盐酸美金刚 · No verified English name | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Chemical Pharmaceutical Factory romanized | Y20170001443 | A | Exact ingredient | 2024/06/06 | CDE |
| 盐酸美金刚 · No verified English name | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20170001437 | A | Exact ingredient | 2022/10/19 | CDE |
| 盐酸美金刚 · No verified English name | Rui Yang Pharmaceutical Co., Ltd. romanized | Y20170001394 | A | Exact ingredient | 2024/01/03 | CDE |
| 盐酸美金刚 · No verified English name | Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20170001383 | A | Exact ingredient | 2024/08/03 | CDE |
| 盐酸美金刚 · No verified English name | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Y20170001374 | I | Exact ingredient | — | CDE |
| 盐酸美金刚 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20170001336 | A | Exact ingredient | 2023/08/11 | CDE |
| 盐酸美金刚 · No verified English name | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Y20170001330 | A | Exact ingredient | 2024/12/18 | CDE |
| 盐酸美金刚 · No verified English name | Changchun Hai Yue Pharma Co., Ltd. romanized | Y20170001254 | A | Exact ingredient | 2023/10/27 | CDE |
| 盐酸美金刚 · No verified English name | Shandong Luo Xin Pharma Group Heng Xin Pharma Co., Ltd. romanized | Y20170001145 | A | Exact ingredient | 2024/11/29 | CDE |
| 盐酸美金刚 · No verified English name | MEGAFINE PHARMA (P) LTD. | Y20170001045 | A | Exact ingredient | 2024/12/11 | CDE |
| 盐酸美金刚 · No verified English name | Alembic Pharmaceuticals Limited | Y20170000855 | A | Exact ingredient | 2024/11/07 | CDE |
| 盐酸美金刚 · No verified English name | TAPI Croatia Industries Ltd. | Y20170000828 | A | Exact ingredient | 2025/06/11 | CDE |
| 盐酸美金刚 · No verified English name | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | Y20170000703 | I | Exact ingredient | — | CDE |
| 盐酸美金刚 · No verified English name | AMSA-ANONIMA MATERIE SINTETICHE & AFFINI S.P.A. | Y20170000608 | A | Exact ingredient | 2025/04/29 | CDE |
| 盐酸美金刚 · No verified English name | Hainan Hui Pu Sen Pharmaceuticals Bio Technology Co., Ltd. romanized | Y20170000427 | 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.
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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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.
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