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Sign in to subscribeAs of 13 November 2026, for Crisaborole Ointment, 26 applications are listed as under review at China's CDE; 11 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.
Last 90 days: Accepted: 3 applicationsNo longer listed under review: 3 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 1 of 1 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: Ointment. 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.
No listings in this group among the displayed brand names.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| EUCRISA | ANACOR PHARMACEUTICALS INC | NDA 207695 · Product no. 001 | OINTMENT | TOPICAL | HUMAN PRESCRIPTION DRUG | 2016/12/14 |
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 |
|---|---|---|---|---|---|---|
| Anacor Pharmaceuticals, Inc. | Pharmacia and Upjohn Company LLC | 国药准字HJ20200022 | 2020/07/29 | 2% | 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: 23 distinct approval numbers and 22 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20264650 | 2%(30g:0.6g) | Category B | XD11AHK139F001010100177 | NHSA |
| Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized | 国药准字H20255867 | 2%(30g:0.6g) | Category B | XD11AHK139F001010100340 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254896 | 2%(30g:0.6g) | Category B | XD11AHK139F001010101503 | NHSA |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H20256013 | 2%(30g:0.6g) | Category B | XD11AHK139F001010101808 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20265204 | 2%(30g∶0.6g) | Category B | XD11AHK139F001010102180 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20264993 | 2%(30g∶0.6g) | Category B | XD11AHK139F001010102959 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20255740 | 2%(30g:0.6g) | Category B | XD11AHK139F001010104522 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20263904 | 2%(30g:0.6g) | Category B | XD11AHK139F001010104606 | NHSA |
| Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20264173 | 2%(30g:0.6g) | Category B | XD11AHK139F001010104942 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256048 | 2%(30g:0.6g) | Category B | XD11AHK139F001010105001 | NHSA |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20264170 | 2%(30g:0.6g) | Category B | XD11AHK139F001010180537 | NHSA |
| Anacor Pharmaceuticals, LLC | 国药准字HJ20200022 | 2% | Category B | XD11AHK139F001010182999 | NHSA |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H20256015 | 2%(30g:0.6g) | Category B | XD11AHK139F001010183191 | NHSA |
| Hebei He Du Pharma Co., Ltd. romanized | 国药准字H20265998 | 2%(30g:0.6g) | Category B | XD11AHK139F001010183394 | NHSA |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H20264314 | 2%(30g:0.6g) | Category B | XD11AHK139F001010183544 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20255380 | 2%(30g:0.6g) | Category B | XD11AHK139F001010183549 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255487 | 2%(30g:0.6g) | Category B | XD11AHK139F001010184221 | NHSA |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264421 | 2%(30g:0.6g) | Category B | XD11AHK139F001010184239 | NHSA |
| Nanjing Wan Rong Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244979 | 2%(30g:0.6g) | Category B | XD11AHK139F001010184314 | NHSA |
| Suzhou Gao Mai Pharma Co., Ltd. romanized | 国药准字H20264385 | 2%(30g:0.6g) | Category B | XD11AHK139F001010184410 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265947 | 2%(30g:0.6g) | Category B | XD11AHK139F001010184564 | NHSA |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254892 | 2%(60g:1.2g) | Category B | XD11AHK139F001010184874 | NHSA |
| Anacor Pharmaceuticals, LLC | 国药准字HJ20200022 | 2% | Category B | XD11AHK139F001020182999 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265948 | 2%(60g:1.2g) | Category B | XD11AHK139F001020184564 | NHSA |
| Anacor Pharmaceuticals, LLC | 国药准字HJ20200022 | 2% | Category B | XD11AHK139F001030182999 | 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: 26 filings and 24 distinct first applicants.
Generic 24 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Haerbin Kui Hua Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2503831 | Generic | 2025/10/30 | Not stated by source | CDE |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601187 | Generic | 2026/05/20 | Not stated by source | CDE |
| Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized | CYHS2502537 | Generic | 2025/07/16 | Not stated by source | CDE |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2503518 | Generic | 2025/09/25 | Not stated by source | CDE |
| Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2504411 | Generic | 2025/12/26 | Not stated by source | CDE |
| Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | CYHS2600855 | Generic | 2026/04/14 | Not stated by source | CDE |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2601367 | Generic | 2026/06/10 | Not stated by source | CDE |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | CYHS2601104 | Generic | 2026/05/13 | Not stated by source | CDE |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600938 | Generic | 2026/04/23 | Not stated by source | CDE |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2600823 | Generic | 2026/04/09 | Not stated by source | CDE |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600433 | Generic | 2026/02/10 | Not stated by source | CDE |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600432 | Generic | 2026/02/10 | Not stated by source | CDE |
| Haerbin Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2600431 | Generic | 2026/02/10 | Not stated by source | CDE |
| Hubei Ke Yi Pharma Co., Ltd. romanized | CYHS2600243 | Generic | 2026/01/21 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2600180 | Generic | 2026/01/14 | Not stated by source | CDE |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600094 | Generic | 2026/01/08 | Not stated by source | CDE |
| Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanized | CYHS2504438 | Generic | 2025/12/27 | Not stated by source | CDE |
| Chongqing Xi Er An Pharma Co., Ltd. romanized | CYHS2504330 | Generic | 2025/12/19 | Not stated by source | CDE |
| Jin Hua Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2504256 | Generic | 2025/12/11 | Not stated by source | CDE |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | CYHS2504114 | Generic | 2025/11/29 | Not stated by source | CDE |
| Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2504104 | Generic | 2025/11/28 | Not stated by source | CDE |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | CYHS2503828 | Generic | 2025/10/29 | Not stated by source | CDE |
| You Hua Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2503633 | Generic | 2025/10/11 | Not stated by source | CDE |
| Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHS2502633 | Generic | 2025/07/22 | Not stated by source | CDE |
| Qilu Pharmaceutical Co., Ltd. | CYHB2601976 | Supplement | 2026/10/29 | Not stated by source | CDE |
| Qilu Pharmaceutical Co., Ltd. | CYHB2601975 | Supplement | 2026/10/29 | Not stated by source | CDE |
Loaded records: 12 filings and 11 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601187 | Generic | 2026/05/20 | Not stated by source | CDE |
| Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | CYHS2600855 | Generic | 2026/04/14 | Not stated by source | CDE |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2601367 | Generic | 2026/06/10 | Not stated by source | CDE |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | CYHS2601104 | Generic | 2026/05/13 | Not stated by source | CDE |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600938 | Generic | 2026/04/23 | Not stated by source | CDE |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2600823 | Generic | 2026/04/09 | Not stated by source | CDE |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600433 | Generic | 2026/02/10 | Not stated by source | CDE |
| Hunan Si Qi Biopharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CYHS2600432 | Generic | 2026/02/10 | Not stated by source | CDE |
| Haerbin Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2600431 | Generic | 2026/02/10 | Not stated by source | CDE |
| Hubei Ke Yi Pharma Co., Ltd. romanized | CYHS2600243 | Generic | 2026/01/21 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2600180 | Generic | 2026/01/14 | Not stated by source | CDE |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600094 | Generic | 2026/01/08 | Not stated by source | CDE |
Non-component matches: 30 companies with A status and 9 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 |
|---|---|---|---|---|---|---|
| 克立硼罗 · No verified English name | Shandong Da Yi Jing Cheng Pharma Co., Ltd. romanized | Y20260000724 | I | Exact ingredient | 2026/09/02 | CDE |
| 克立硼罗 · No verified English name | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20260000008 | I | Exact ingredient | 2026/02/03 | CDE |
| 克立硼罗 · No verified English name | Shandong Bo Yuan Pharma Co., Ltd. romanized | Y20250001376 | I | Exact ingredient | 2025/12/17 | CDE |
| 克立硼罗 · No verified English name | Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized | Y20250001097 | I | Exact ingredient | 2025/10/16 | CDE |
| 克立硼罗 · No verified English name | Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20250000715 | I | Exact ingredient | 2025/08/14 | CDE |
| 克立硼罗 · No verified English name | Zhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanized | Y20250000789 | I | Exact ingredient | 2025/08/06 | CDE |
| 克立硼罗 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20250000473 | A | Exact ingredient | 2026/11/04 | CDE |
| 克立硼罗 · No verified English name | Lanzhou Dong Rui Pharmaceutical Co., Ltd. romanized | Y20250000195 | I | Exact ingredient | 2025/03/18 | CDE |
| 克立硼罗 · No verified English name | Zhejiang Jiu Zhou Pharma Co., Ltd. romanized | Y20240001350 | A | Exact ingredient | 2026/06/01 | CDE |
| 克立硼罗 · No verified English name | Ha Yao Group San Jing Ming Shui Pharma Co., Ltd. romanized | Y20240001304 | I | Exact ingredient | 2024/12/12 | CDE |
| 克立硼罗 · No verified English name | Hainan Huluwa Pharmaceutical Group Co., Ltd. | Y20240001257 | I | Exact ingredient | 2024/12/04 | CDE |
| 克立硼罗 · No verified English name | Jiangsu Run An Pharmaceutical Co., Ltd. romanized | Y20240001060 | A | Exact ingredient | 2026/05/15 | CDE |
| 克立硼罗 · No verified English name | Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20240001071 | A | Exact ingredient | 2026/04/29 | CDE |
| 克立硼罗 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20240000682 | A | Exact ingredient | 2025/10/22 | CDE |
| 克立硼罗 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20240000468 | A | Exact ingredient | 2025/11/14 | CDE |
| 克立硼罗 · No verified English name | Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20240000561 | A | Exact ingredient | 2026/04/10 | CDE |
| 克立硼罗 · No verified English name | Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | Y20240000380 | A | Exact ingredient | 2025/09/30 | CDE |
| 克立硼罗 · No verified English name | Yi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanized | Y20240000269 | A | Exact ingredient | 2025/09/15 | CDE |
| 克立硼罗 · No verified English name | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20240000361 | A | Exact ingredient | 2025/12/17 | CDE |
| 克立硼罗 · No verified English name | Anhui Pu Li Pharma Co., Ltd. romanized | Y20240000303 | A | Exact ingredient | 2026/09/03 | CDE |
| 克立硼罗 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20230001078 | A | Exact ingredient | 2025/06/26 | CDE |
| 克立硼罗 · No verified English name | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20230000744 | A | Exact ingredient | 2026/11/11 | CDE |
| 克立硼罗 · No verified English name | Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20230000985 | A | Exact ingredient | 2026/05/20 | CDE |
| 克立硼罗 · No verified English name | Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | Y20230000967 | A | Exact ingredient | 2026/08/08 | CDE |
| 克立硼罗 · No verified English name | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | Y20230000954 | A | Exact ingredient | 2025/08/11 | CDE |
| 克立硼罗 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20230000908 | A | Exact ingredient | 2026/05/20 | CDE |
| 克立硼罗 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20230000653 | A | Exact ingredient | 2024/12/13 | CDE |
| 克立硼罗 · No verified English name | Shao Xing Min Sheng Pharmaceuticals Co., Ltd. romanized | Y20230000426 | A | Exact ingredient | 2025/03/25 | CDE |
| 克立硼罗 · No verified English name | Sichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanized | Y20230000644 | A | Exact ingredient | 2025/06/03 | CDE |
| 克立硼罗 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20230000380 | A | Exact ingredient | 2025/03/19 | CDE |
| 克立硼罗 · No verified English name | Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20230000260 | A | Exact ingredient | 2025/08/01 | CDE |
| 克立硼罗 · No verified English name | Qilu Pharmaceutical Co., Ltd. | Y20230000191 | A | Exact ingredient | 2024/10/25 | CDE |
| 克立硼罗 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20220001301 | A | Exact ingredient | 2024/08/15 | CDE |
| 克立硼罗 · No verified English name | Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20220001304 | A | Exact ingredient | 2025/06/26 | CDE |
| 克立硼罗 · No verified English name | Jiangxi Tong He Pharma Co., Ltd. romanized | Y20220001177 | A | Exact ingredient | 2026/11/10 | CDE |
| 克立硼罗 · No verified English name | Zhang Zhi Shi Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized | Y20220001261 | A | Exact ingredient | 2026/07/11 | CDE |
| 克立硼罗 · No verified English name | Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20220001073 | A | Exact ingredient | 2026/06/16 | CDE |
| 克立硼罗 · No verified English name | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Y20220000559 | A | Exact ingredient | 2024/02/08 | CDE |
| 克立硼罗 · No verified English name | Honour Lab Limited, Unit - III romanized | Y20210000553 | A | Exact ingredient | 2025/07/29 | 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.
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.
CYHB2601958
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2026/10/26
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2502124
Fact date: 2026/11/11 · Site observation date: 2026/11/11
Accepted: 2025/06/14
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501906
Fact date: 2026/11/03 · Site observation date: 2026/11/03
Accepted: 2025/05/28
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHB2601976
Fact date: 2026/10/29 · Site observation date: 2026/10/30
View source ↗CYHB2601975
Fact date: 2026/10/29 · Site observation date: 2026/10/30
View source ↗CYHB2601958
Fact date: 2026/10/26 · Site observation date: 2026/10/27
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.
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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