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Sign in to subscribeAs of 13 November 2026, for Eldecalcitol Soft Capsules, 8 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 14 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
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: 14 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| Beijing Si Li An Pharma Co., Ltd. romanized | Beijing Si Li An Pharma Co., Ltd. romanized | 国药准字H20264357 | 2026/05/19 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256105 | 2025/12/03 | 0.5μg | Not stated by source | CDE |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256106 | 2025/12/03 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20255266 | 2025/09/02 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254209 | 2025/05/20 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254208 | 2025/05/20 | 0.5μg | Not stated by source | CDE |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20253727 | 2025/03/25 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20253728 | 2025/03/25 | 0.5μg | Generic approved under the new chemical-drug registration classification | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20253039 | 2025/01/02 | 0.5μg | Generic approved under the new chemical-drug registration classification | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20253040 | 2025/01/02 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244646 | 2024/08/05 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20244479 | 2024/07/22 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20244480 | 2024/07/22 | 0.5μg | Generic approved under the new chemical-drug registration classification | CDE |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20243290 | 2024/02/23 | 0.5μg | Generic approved under the new chemical-drug registration classification | CDE |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20243289 | 2024/02/23 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234466 | 2023/11/07 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 2023/11/07 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234465 | 2023/11/07 | 0.5μg | Generic approved under the new chemical-drug registration classification | CDE |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 2023/02/21 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233063 | 2023/01/19 | 0.75μg | Generic approved under the new chemical-drug registration classification | CDE |
| Henan Tai Feng Bio Technology Co., Ltd. romanized | Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20247029 | 2022/09/30 | 0.5μg | Generic approved under the new chemical-drug registration classification | CDE |
| Henan Tai Feng Bio Technology Co., Ltd. romanized | Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20223700 | 2022/09/30 | 0.75μg | 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.
Loaded records: 20 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 0.75μg | Category B | XA11CCA351E002010101121 | NHSA |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized | 国药准字H20254209 | 0.75μg | Category B | XA11CCA351E002010101503 | NHSA |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20253039 | 0.5μg | Category B | XA11CCA351E002010101523 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244646 | 0.75μg | Category B | XA11CCA351E002010102180 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20223700 | 0.75μg | Category B | XA11CCA351E002010103013 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20255266 | 0.75µg | Category B | XA11CCA351E002010104188 | NHSA |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 0.75μg | Category B | XA11CCA351E002010104586 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244479 | 0.75μg | Category B | XA11CCA351E002010107011 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20243289 | 0.75μg | Category B | XA11CCA351E002010109981 | NHSA |
| Chugai Pharmaceutical Co., Ltd | 国药准字HJ20200057 | 0.5μg | Category B | XA11CCA351E002010179189 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233063 | 0.75μg | Category B | XA11CCA351E002010180937 | NHSA |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234466 | 0.75μg | Category B | XA11CCA351E002010181812 | NHSA |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256105 | 0.5μg | Category B | XA11CCA351E002010184386 | NHSA |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 0.75μg | Category B | XA11CCA351E002010201121 | NHSA |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized | 国药准字H20254209 | 0.75μg | Category B | XA11CCA351E002010201503 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20223700 | 0.75μg | Category B | XA11CCA351E002010203013 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20255266 | 0.75µg | Category B | XA11CCA351E002010204188 | NHSA |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 0.75μg | Category B | XA11CCA351E002010204586 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244479 | 0.75μg | Category B | XA11CCA351E002010207011 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20243289 | 0.75μg | Category B | XA11CCA351E002010209981 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233063 | 0.75μg | Category B | XA11CCA351E002010280937 | NHSA |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234466 | 0.75μg | Category B | XA11CCA351E002010281812 | NHSA |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256105 | 0.5μg | Category B | XA11CCA351E002010284386 | NHSA |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 0.75μg | Category B | XA11CCA351E002010301121 | NHSA |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized | 国药准字H20254209 | 0.75μg | Category B | XA11CCA351E002010301503 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20223700 | 0.75μg | Category B | XA11CCA351E002010303013 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20255266 | 0.75µg | Category B | XA11CCA351E002010304188 | NHSA |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 0.75μg | Category B | XA11CCA351E002010304586 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244479 | 0.75μg | Category B | XA11CCA351E002010307011 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233063 | 0.75μg | Category B | XA11CCA351E002010380937 | NHSA |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234466 | 0.75μg | Category B | XA11CCA351E002010381812 | NHSA |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256105 | 0.5μg | Category B | XA11CCA351E002010384386 | NHSA |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 0.75μg | Category B | XA11CCA351E002010401121 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20223700 | 0.75μg | Category B | XA11CCA351E002010403013 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20255266 | 0.75µg | Category B | XA11CCA351E002010404188 | NHSA |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 0.75μg | Category B | XA11CCA351E002010404586 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244479 | 0.75μg | Category B | XA11CCA351E002010407011 | NHSA |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234466 | 0.75μg | Category B | XA11CCA351E002010481812 | NHSA |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 0.75μg | Category B | XA11CCA351E002010501121 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20223700 | 0.75μg | Category B | XA11CCA351E002010503013 | NHSA |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 0.75μg | Category B | XA11CCA351E002010504586 | NHSA |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20234468 | 0.75μg | Category B | XA11CCA351E002010601121 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20223700 | 0.75μg | Category B | XA11CCA351E002010603013 | NHSA |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 国药准字H20233213 | 0.75μg | Category B | XA11CCA351E002010604586 | NHSA |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20253040 | 0.75μg | Category B | XA11CCA351E002020101523 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20247029 | 0.5μg | Category B | XA11CCA351E002020103013 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244480 | 0.5μg | Category B | XA11CCA351E002020107011 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20243290 | 0.5μg | Category B | XA11CCA351E002020109981 | NHSA |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234465 | 0.5μg | Category B | XA11CCA351E002020181812 | NHSA |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256106 | 0.75μg | Category B | XA11CCA351E002020184386 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20247029 | 0.5μg | Category B | XA11CCA351E002020203013 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244480 | 0.5μg | Category B | XA11CCA351E002020207011 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20243290 | 0.5μg | Category B | XA11CCA351E002020209981 | NHSA |
| Chugai Pharmaceutical Co., Ltd | 国药准字HJ20200058 | 0.75μg | Category B | XA11CCA351E002020279189 | NHSA |
| Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | 国药准字H20234465 | 0.5μg | Category B | XA11CCA351E002020281812 | NHSA |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256106 | 0.75μg | Category B | XA11CCA351E002020284386 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20247029 | 0.5μg | Category B | XA11CCA351E002020303013 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244480 | 0.5μg | Category B | XA11CCA351E002020307011 | NHSA |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 国药准字H20256106 | 0.75μg | Category B | XA11CCA351E002020384386 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20247029 | 0.5μg | Category B | XA11CCA351E002020403013 | NHSA |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20244480 | 0.5μg | Category B | XA11CCA351E002020407011 | NHSA |
| Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20247029 | 0.5μg | Category B | XA11CCA351E002020503013 | 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: 8 filings and 5 distinct first applicants.
Supplement 1 · Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | CYHB2601133 | Supplement | 2026/06/16 | Not stated by source | CDE |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | CYHS2601063 | Generic | 2026/05/09 | Not stated by source | CDE |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | CYHS2601061 | Generic | 2026/05/09 | Not stated by source | CDE |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | CYHS2600421 | Generic | 2026/02/10 | Not stated by source | CDE |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | CYHS2600420 | Generic | 2026/02/10 | Not stated by source | CDE |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized | CYHS2504191 | Generic | 2025/12/05 | Not stated by source | CDE |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized | CYHS2504190 | Generic | 2025/12/05 | Not stated by source | CDE |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized | CYHS2503728 | Generic | 2025/10/18 | 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 |
|---|---|---|---|---|---|
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | CYHS2601063 | Generic | 2026/05/09 | Not stated by source | CDE |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | CYHS2601061 | Generic | 2026/05/09 | Not stated by source | CDE |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | CYHS2600421 | Generic | 2026/02/10 | Not stated by source | CDE |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | CYHS2600420 | Generic | 2026/02/10 | Not stated by source | CDE |
Non-component matches: 11 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 艾地骨化醇 · No verified English name | Changchun Hai Yue Pharma Co., Ltd. romanized | Y20240000452 | I | Exact ingredient | 2024/05/13 | CDE |
| 艾地骨化醇 · No verified English name | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | Y20230001070 | A | Exact ingredient | 2025/02/26 | CDE |
| 艾地骨化醇 · No verified English name | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | Y20230000401 | A | Exact ingredient | 2025/04/08 | CDE |
| 艾地骨化醇 · No verified English name | Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanized | Y20230000482 | A | Exact ingredient | 2026/06/02 | CDE |
| 艾地骨化醇 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20230000297 | A | Exact ingredient | 2026/09/12 | CDE |
| 艾地骨化醇 · No verified English name | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | Y20220000173 | A | Exact ingredient | 2026/06/03 | CDE |
| 艾地骨化醇 · No verified English name | Da Lian Mei Chuang Pharma Co., Ltd. romanized | Y20220000043 | A | Exact ingredient | 2026/09/21 | CDE |
| 艾地骨化醇 · No verified English name | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20210000904 | A | Exact ingredient | 2023/06/28 | CDE |
| 艾地骨化醇 · No verified English name | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized | Y20210000737 | A | Exact ingredient | 2026/10/28 | CDE |
| 艾地骨化醇 · No verified English name | Wen Zhou Hai He Pharma Co., Ltd. romanized | Y20210000727 | A | Exact ingredient | 2023/03/03 | CDE |
| 艾地骨化醇 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20210000439 | A | Exact ingredient | 2022/10/27 | CDE |
| 艾地骨化醇 · No verified English name | Nissan Chemical Corporation | Y20200000962 | A | Exact ingredient | 2025/09/11 | 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.
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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