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Metoprolol Succinate Extended-release Capsules

As of 13 November 2026, for Metoprolol Succinate Extended-release Capsules, 4 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 6 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as KAPSPARGO SPRINKLE (NDA 210428, SUN PHARMA INDUSTRIES LTD).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

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: Extended-release Capsules. 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 nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
KAPSPARGO SPRINKLE SUN PHARMA INDUSTRIES LTD NDA 210428 · Product no. 001, 002, 003, 004 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2018/01/26

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
TOPROL-XL MELINTA THERAPEUTICS LLC A WHOLLY OWNED SUB OF CORMEDIX INC NDA 019962 · Product no. 001, 002, 003 TABLET, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 1992/01/10
TOPROL-XL MELINTA THERAPEUTICS LLC A WHOLLY OWNED SUB OF CORMEDIX INC NDA 019962 · Product no. 004 TABLET, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2001/02/05

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.

Ingredient cross-list details ↗

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.

Chemical-drug catalogue

Loaded records: 6 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 6 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Shanghai Hui Yong Pharmaceutical Co., Ltd. romanizedShanghai Hui Yong Pharmaceutical Co., Ltd. romanized国药准字H202638562026/04/0747.5mgGeneric approved under the new chemical-drug registration classificationCDE
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202562692025/12/1695mgGeneric approved under the new chemical-drug registration classificationCDE
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202562702025/12/1623.75mgGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanizedNingbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H202561822025/12/0947.5mgGeneric approved under the new chemical-drug registration classificationCDE
Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanizedZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202490962024/10/1647.5mgGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Lu Yin Pharma Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202442002024/06/2847.5mgGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Lu Yin Pharma Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202441992024/06/2895mgGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Lu Yin Pharma Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202441982024/06/2823.75mgGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H202437172024/05/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H202437162024/05/15See sourceGeneric approved under the new chemical-drug registration classificationCDE

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: 10 distinct approval numbers and 6 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010104127NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024419995mgCategory BXC07ABM062E003010104240NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025627023.75mgCategory BXC07ABM062E003010105199NHSA
Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized国药准字H2024909647.5mgCategory BXC07ABM062E003010183544NHSA
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2025618247.5mgCategory BXC07ABM062E003010184135NHSA
Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized国药准字H2026385647.5mgCategory BXC07ABM062E003010185534NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010204127NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025627023.75mgCategory BXC07ABM062E003010205199NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010304127NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025627023.75mgCategory BXC07ABM062E003010305199NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010404127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010504127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010604127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010704127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010804127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003010904127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011004127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011104127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011204127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011304127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011404127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011504127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011604127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011704127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011804127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003011904127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371623.75mgCategory BXC07ABM062E003012004127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020104127NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024419823.75mgCategory BXC07ABM062E003020104240NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025626995mgCategory BXC07ABM062E003020105199NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020204127NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025626995mgCategory BXC07ABM062E003020205199NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020304127NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025626995mgCategory BXC07ABM062E003020305199NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020404127NHSA
Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H2025626995mgCategory BXC07ABM062E003020405199NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020504127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020604127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020704127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020804127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003020904127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021004127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021104127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021204127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021304127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021404127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021504127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021604127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021704127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021804127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003021904127NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H2024371747.5mgCategory BXC07ABM062E003022004127NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030104240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030204240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030304240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030404240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030504240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030604240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030704240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030804240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003030904240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003031004240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003031104240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003031204240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003040104240NHSA
Yan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H2024420047.5mgCategory BXC07ABM062E003050104240NHSA

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: 4 filings and 2 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanizedCYHS2602343Generic2026/09/20Not stated by sourceCDE
Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanizedCYHS2602342Generic2026/09/20Not stated by sourceCDE
Shandong Hua Su Pharmaceutical Co., Ltd. romanizedCYHS2601415Generic2026/06/15Not stated by sourceCDE
Shandong Hua Su Pharmaceutical Co., Ltd. romanizedCYHS2601414Generic2026/06/15Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanizedCYHS2602343Generic2026/09/20Not stated by sourceCDE
Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanizedCYHS2602342Generic2026/09/20Not stated by sourceCDE
Shandong Hua Su Pharmaceutical Co., Ltd. romanizedCYHS2601415Generic2026/06/15Not stated by sourceCDE
Shandong Hua Su Pharmaceutical Co., Ltd. romanizedCYHS2601414Generic2026/06/15Not stated by sourceCDE
API registrations

Non-component matches: 19 companies with A status and 7 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
酒石酸美托洛尔 · No verified English nameAnhui Nuo Er Kang Pharma Co., Ltd. romanizedY20260000444ISalt-normalized ingredient2026/07/16CDE
琥珀酸美托洛尔 · No verified English nameAnhui Nuo Er Kang Pharma Co., Ltd. romanizedY20260000462IExact ingredient2026/07/03CDE
琥珀酸美托洛尔 · No verified English nameSun Pharmaceutical Industries LimitedY20240001575IExact ingredient2025/04/16CDE
酒石酸美托洛尔 · No verified English nameAtul Bioscience LtdY20240001015ISalt-normalized ingredient2025/02/17CDE
琥珀酸美托洛尔 · No verified English nameIpca Laboratories LimitedY20230001162AExact ingredient2026/04/03CDE
酒石酸美托洛尔 · No verified English nameBai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanizedY20240000368ASalt-normalized ingredient2025/12/09CDE
琥珀酸美托洛尔 · No verified English nameShandong Hua Su Pharmaceutical Co., Ltd. romanizedY20240000199AExact ingredient2026/09/21CDE
琥珀酸美托洛尔 · No verified English nameATUL BIOSCIENCE LTD.Y20230000090AExact ingredient2024/11/26CDE
琥珀酸美托洛尔 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20230000348AExact ingredient2026/03/12CDE
酒石酸美托洛尔 · No verified English nameIpca Laboratories LimitedY20220000474ASalt-normalized ingredient2024/08/07CDE
琥珀酸美托洛尔 · No verified English nameDr.Reddy's Laboratories Ltd.Y20220000109AExact ingredient2024/01/16CDE
琥珀酸美托洛尔 · No verified English nameShandong Qidu Pharmaceutical Co., Ltd.Y20210000268AExact ingredient2026/08/25CDE
琥珀酸美托洛尔 · No verified English nameCTX Lifesciences Pvt. Ltd.Y20190021559AExact ingredient2026/09/17CDE
琥珀酸美托洛尔 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20200001420AExact ingredient2023/07/06CDE
琥珀酸美托洛尔 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20200000203AExact ingredient2026/04/27CDE
酒石酸美托洛尔 · No verified English nameAstraZeneca ABY20190009941ASalt-normalized ingredient—CDE
酒石酸美托洛尔 · No verified English nameAstraZeneca ABY20190009940ASalt-normalized ingredient—CDE
酒石酸美托洛尔 · No verified English nameZhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanizedY20190009774ASalt-normalized ingredient2025/11/25CDE
酒石酸美托洛尔 · No verified English nameGuangzhou Bai Yun Shan Han Fang Xian Dai Pharma Co., Ltd. romanizedY20190007575ASalt-normalized ingredient2026/06/17CDE
酒石酸美托洛尔 · No verified English nameShanghai Xin Yi Bai Lu Da Pharma Co., Ltd. romanizedY20190006716ASalt-normalized ingredient2023/03/24CDE
酒石酸美托洛尔 · No verified English nameChangzhou Si Yao Pharmaceutical Co., Ltd. romanizedY20190004561ASalt-normalized ingredient2026/03/18CDE
琥珀酸美托洛尔 · No verified English nameZhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanizedY20190000080AExact ingredient2026/04/08CDE
琥珀酸美托洛尔 · No verified English nameZhejiang Hai Xiang Chuan Nan Pharma Co., Ltd. romanizedY20180001385AExact ingredient2026/10/28CDE
酒石酸美托洛尔 · No verified English nameAstraZeneca ABY20170001948ASalt-normalized ingredient2024/09/24CDE
酒石酸美托洛尔 · No verified English nameAstraZeneca ABY20170001947ASalt-normalized ingredient2024/09/24CDE
酒石酸美托洛尔 · No verified English nameSun Pharmaceutical Industries LimitedY20170001466ASalt-normalized ingredient2024/11/07CDE
琥珀酸美托洛尔 · No verified English nameMOEHS IBERICA S.L.Y20170001403AExact ingredient2026/10/16CDE
琥珀酸美托洛尔 · No verified English nameName not romanizedY20170001066IExact ingredient—CDE
琥珀酸美托洛尔 · No verified English namePOLYDRUG LABORATORIES PVT. LTD.Y20170001016IExact ingredient—CDE
酒石酸美托洛尔 · No verified English namePOLYDRUG LABORATORIES PVT. LTD.Y20170000942ISalt-normalized ingredient—CDE
酒石酸美托洛尔 · No verified English nameCTX Lifesciences Pvt. Ltd.Y20170000853ASalt-normalized ingredient2026/01/02CDE
琥珀酸美托洛尔 · No verified English nameYi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedY20170000556AExact ingredient2026/07/14CDE

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.

  1. 2026/09/20Accepted

    Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized

    CYHS2602343

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/09/20Accepted

    Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized

    CYHS2602342

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗

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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