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Sign in to subscribeAs of 13 November 2026, for Pentoxifylline Modified Release Tablets, 6 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 17 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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 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: Modified Release 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.
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 |
|---|---|---|---|---|---|---|
| TRENTAL | VALIDUS PHARMACEUTICALS LLC | NDA 018631 · Product no. 001 | TABLET, EXTENDED RELEASE | ORAL | HUMAN PRESCRIPTION DRUG | 1984/08/30 |
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: 17 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 16 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 Xing Hao Pharmaceuticals Co., Ltd. romanized | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H20265835 | 2026/09/02 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265601 | 2026/08/04 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H20265021 | 2026/06/30 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | Guangdong An Nuo Pharma Co., Ltd. romanized | 国药准字H20264886 | 2026/06/17 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20264838 | 2026/06/17 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H20263517 | 2026/03/03 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized | Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20263516 | 2026/03/03 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Hui Ju Pharma Co., Ltd. romanized | Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20263473 | 2026/02/25 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256070 | 2025/11/25 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H20255883 | 2025/11/04 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20255377 | 2025/09/09 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H20255347 | 2025/09/09 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20255255 | 2025/08/26 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20255008 | 2025/07/29 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20254845 | 2025/07/15 | 0.4g | Not stated by source | CDE |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | Jiangsu Yong An Pharmaceutical Co., Ltd. romanized | 国药准字H20253544 | 2025/03/04 | 0.4g | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20233310 | 2023/03/21 | 0.4g | 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: 18 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H20265835 | 0.4g | Category B | XC04ADJ014A010010100198 | NHSA |
| Jiangsu Hui Ju Pharma Co., Ltd. romanized | 国药准字H20263473 | 0.4g | Category B | XC04ADJ014A010010101411 | NHSA |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H20255883 | 0.4g | Category B | XC04ADJ014A010010101679 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20233310 | 0.4g | Category B | XC04ADJ014A010010102763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10970265 | 0.4g | Category B | XC04ADJ014A010010102770 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20255008 | 0.4g | Category B | XC04ADJ014A010010102777 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20255255 | 0.4g | Category B | XC04ADJ014A010010104111 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265601 | 0.4g | Category B | XC04ADJ014A010010104685 | NHSA |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H20263517 | 0.4g | Category B | XC04ADJ014A010010105781 | NHSA |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20264886 | 0.4g | Category B | XC04ADJ014A010010183014 | NHSA |
| Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized | 国药准字H20256017 | 0.4g | Category B | XC04ADJ014A010010183114 | NHSA |
| Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256070 | 0.4g | Category B | XC04ADJ014A010010183238 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264838 | 0.4g | Category B | XC04ADJ014A010010184019 | NHSA |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254845 | 0.4g | Category B | XC04ADJ014A010010184160 | NHSA |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | 国药准字H20255347 | 0.4g | Category B | XC04ADJ014A010010184179 | NHSA |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255377 | 0.4g | Category B | XC04ADJ014A010010184207 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253544 | 0.4g | Category B | XC04ADJ014A010010184221 | NHSA |
| Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263516 | 0.4g | Category B | XC04ADJ014A010010184715 | NHSA |
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H20265835 | 0.4g | Category B | XC04ADJ014A010010200198 | NHSA |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H20255883 | 0.4g | Category B | XC04ADJ014A010010201679 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20233310 | 0.4g | Category B | XC04ADJ014A010010202763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10970265 | 0.4g | Category B | XC04ADJ014A010010202770 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20255255 | 0.4g | Category B | XC04ADJ014A010010204111 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265601 | 0.4g | Category B | XC04ADJ014A010010204685 | NHSA |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H20263517 | 0.4g | Category B | XC04ADJ014A010010205781 | NHSA |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20264886 | 0.4g | Category B | XC04ADJ014A010010283014 | NHSA |
| Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized | 国药准字H20256017 | 0.4g | Category B | XC04ADJ014A010010283114 | NHSA |
| Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256070 | 0.4g | Category B | XC04ADJ014A010010283238 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264838 | 0.4g | Category B | XC04ADJ014A010010284019 | NHSA |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254845 | 0.4g | Category B | XC04ADJ014A010010284160 | NHSA |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | 国药准字H20255347 | 0.4g | Category B | XC04ADJ014A010010284179 | NHSA |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255377 | 0.4g | Category B | XC04ADJ014A010010284207 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253544 | 0.4g | Category B | XC04ADJ014A010010284221 | NHSA |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H20255883 | 0.4g | Category B | XC04ADJ014A010010301679 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20233310 | 0.4g | Category B | XC04ADJ014A010010302763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10970265 | 0.4g | Category B | XC04ADJ014A010010302770 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20255255 | 0.4g | Category B | XC04ADJ014A010010304111 | NHSA |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20265601 | 0.4g | Category B | XC04ADJ014A010010304685 | NHSA |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20264886 | 0.4g | Category B | XC04ADJ014A010010383014 | NHSA |
| Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized | 国药准字H20256017 | 0.4g | Category B | XC04ADJ014A010010383114 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264838 | 0.4g | Category B | XC04ADJ014A010010384019 | NHSA |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254845 | 0.4g | Category B | XC04ADJ014A010010384160 | NHSA |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255377 | 0.4g | Category B | XC04ADJ014A010010384207 | NHSA |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H20255883 | 0.4g | Category B | XC04ADJ014A010010401679 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10970265 | 0.4g | Category B | XC04ADJ014A010010402770 | NHSA |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20255255 | 0.4g | Category B | XC04ADJ014A010010404111 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264838 | 0.4g | Category B | XC04ADJ014A010010484019 | NHSA |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254845 | 0.4g | Category B | XC04ADJ014A010010484160 | NHSA |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255377 | 0.4g | Category B | XC04ADJ014A010010484207 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10970265 | 0.4g | Category B | XC04ADJ014A010010502770 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264838 | 0.4g | Category B | XC04ADJ014A010010584019 | NHSA |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H20255377 | 0.4g | Category B | XC04ADJ014A010010584207 | NHSA |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264838 | 0.4g | Category B | XC04ADJ014A010010684019 | 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 6 distinct first applicants.
Supplement 1 · Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Guo Gao Pharma Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized | CYHB2601752 | Supplement | 2026/09/17 | Not stated by source | CDE |
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2500044 | Generic | 2025/01/04 | Not stated by source | CDE |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized | CYHS2600403 | Generic | 2026/02/07 | Not stated by source | CDE |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | CYHS2601283 | Generic | 2026/06/04 | Not stated by source | CDE |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2600230 | Generic | 2026/01/20 | Not stated by source | CDE |
| Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2403035 | Generic | 2024/09/12 | Not stated by source | CDE |
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized | CYHS2600403 | Generic | 2026/02/07 | Not stated by source | CDE |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | CYHS2601283 | Generic | 2026/06/04 | Not stated by source | CDE |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2600230 | Generic | 2026/01/20 | Not stated by source | CDE |
Non-component matches: 15 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 |
|---|---|---|---|---|---|---|
| 己酮可可碱 · No verified English name | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20250000604 | I | Exact ingredient | 2025/07/16 | CDE |
| 己酮可可碱 · No verified English name | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized | Y20240000724 | I | Exact ingredient | 2024/07/24 | CDE |
| 己酮可可碱 · No verified English name | Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20240000402 | A | Exact ingredient | 2025/12/10 | CDE |
| 己酮可可碱 · No verified English name | Chi Feng Wan Ze Pharma Co., Ltd. romanized | Y20230001239 | A | Exact ingredient | 2025/11/03 | CDE |
| 己酮可可碱 · No verified English name | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | Y20230000412 | A | Exact ingredient | 2025/04/07 | CDE |
| 己酮可可碱 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20230000230 | A | Exact ingredient | 2025/08/10 | CDE |
| 己酮可可碱 · No verified English name | SUN PHARMACEUTICAL INDUSTRIES LTD. | Y20220000937 | A | Exact ingredient | 2024/11/07 | CDE |
| 己酮可可碱 · No verified English name | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20220000743 | A | Exact ingredient | 2024/08/10 | CDE |
| 己酮可可碱 · No verified English name | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized | Y20220000799 | A | Exact ingredient | 2024/05/30 | CDE |
| 己酮可可碱 · No verified English name | Hikal Limited | Y20210001229 | I | Exact ingredient | 2022/04/29 | CDE |
| 己酮可可碱 · No verified English name | PHARMACEUTICAL WORKS POLPHARMA S.A. | Y20210000211 | A | Exact ingredient | 2024/07/09 | CDE |
| 己酮可可碱 · No verified English name | Chongqing Rui Po Lai Pharmaceutical Co., Ltd. romanized | Y20210000669 | A | Exact ingredient | 2025/01/27 | CDE |
| 己酮可可碱 · No verified English name | FLEMING LABORATORIES LTD | Y20210000649 | A | Exact ingredient | 2025/06/08 | CDE |
| 己酮可可碱 · No verified English name | BAKUL PHARMA PRIVATE LIMITED | Y20200001449 | A | Exact ingredient | 2025/12/25 | CDE |
| 己酮可可碱 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20200001394 | A | Exact ingredient | 2026/10/13 | CDE |
| 己酮可可碱 · No verified English name | SOLARA ACTIVE PHARMA SCIENCES LIMITED | Y20200001064 | A | Exact ingredient | 2023/05/16 | CDE |
| 己酮可可碱 · No verified English name | Shi Yao Innovation Pharmaceutical Co., Ltd. romanized | Y20190005020 | A | Exact ingredient | 2025/06/12 | CDE |
| 己酮可可碱 · No verified English name | Sanofi India Limited | Y20170001717 | I | Exact ingredient | — | CDE |
| 己酮可可碱 · No verified English name | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Y20170000764 | A | Exact ingredient | 2026/07/24 | 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.
CYHB2601752
Fact date: 2026/09/17 · Site observation date: 2026/10/21
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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