药格局YaoGeJu

Public drug landscapesDrug landscape

司美格鲁肽注射液

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

Last 90 days: Accepted: 16 applicationsSupplement delivery: 10 applications

Current coverage may be incomplete

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Complete CDE snapshot
2026/11/10 07:27
Matching scope
Same generic name; dosage forms and combinations kept separate

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.

Chemical-drug catalogue

Loaded records: 0 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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 7 distinct approval numbers and 2 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Novo Nordisk A/S 国药准字SJ20240020 3.2mg/ml,3ml Not stated by sourceXA10BJS279B002010178997NHSA
Novo Nordisk Pharma AG 国药准字SJ20210014 1.34mg/ml,1.5ml(预填充注射笔) Category B (乙) XA10BJS279B002010283568NHSA
Novo Nordisk A/S 国药准字SJ20240021 2.27mg/ml,3ml Not stated by sourceXA10BJS279B002020178997NHSA
Novo Nordisk Pharma AG 国药准字SJ20210015 1.34mg/ml,3ml(预填充注射笔) Category B (乙) XA10BJS279B002020283568NHSA
Novo Nordisk A/S 国药准字SJ20240022 1.34mg/ml,3ml Not stated by sourceXA10BJS279B002030178997NHSA
Novo Nordisk A/S 国药准字SJ20240023 1.34mg/ml,1.5ml Not stated by sourceXA10BJS279B002040178997NHSA
Novo Nordisk A/S 国药准字SJ20240024 0.68mg/ml,1.5ml Not stated by sourceXA10BJS279B002050178997NHSA

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: 92 filings and 17 distinct first applicants.

New drug 84 · Generic 8

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600057 New drug2026/04/22Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600056 New drug2026/04/22Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600055 New drug2026/04/22Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600054 New drug2026/04/22Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600053 New drug2026/04/09Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600052 New drug2026/04/09Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600051 New drug2026/04/09Not stated by sourceCDE
江苏诺泰澳赛诺生物制药股份有限公司 CXHS2600050 New drug2026/04/09Not stated by sourceCDE
复星万邦(江苏)医药集团有限公司 CXSS2500122 New drug2025/11/07Not stated by sourceCDE
复星万邦(江苏)医药集团有限公司 CXSS2500121 New drug2025/11/07Not stated by sourceCDE
复星万邦(江苏)医药集团有限公司 CXSS2500120 New drug2025/11/07Not stated by sourceCDE
复星万邦(江苏)医药集团有限公司 CXSS2500119 New drug2025/11/07Not stated by sourceCDE
连云港润众制药有限公司 CXSS2600119 New drug2026/08/04Not stated by sourceCDE
连云港润众制药有限公司 CXSS2600118 New drug2026/08/04Not stated by sourceCDE
连云港润众制药有限公司 CXSS2600117 New drug2026/08/04Not stated by sourceCDE
连云港润众制药有限公司 CXSS2600116 New drug2026/08/04Not stated by sourceCDE
连云港润众制药有限公司 CXSS2600115 New drug2026/08/04Not stated by sourceCDE
连云港润众制药有限公司 CXSS2500140 New drug2025/12/11Not stated by sourceCDE
连云港润众制药有限公司 CXSS2500139 New drug2025/12/11Not stated by sourceCDE
广州白云山拜迪生物医药有限公司;南京赛诺生物制药有限公司 CXSL2601064 New drug2026/09/24Not stated by sourceCDE
广州白云山拜迪生物医药有限公司;南京赛诺生物制药有限公司 CXSL2601063 New drug2026/09/24Not stated by sourceCDE
质肽药业(泰州)有限公司 CXSS2600125 New drug2026/08/17Not stated by sourceCDE
质肽药业(泰州)有限公司 CXSS2600124 New drug2026/08/17Not stated by sourceCDE
广州白云山拜迪生物医药有限公司 CXSL2601141 New drug2026/10/19Not stated by sourceCDE
广州白云山拜迪生物医药有限公司 CXSL2601140 New drug2026/10/19Not stated by sourceCDE
天津天士力之骄药业有限公司 CYHL2600100 Generic2026/09/16Not stated by sourceCDE
天津天士力之骄药业有限公司 CYHL2600099 Generic2026/09/16Not stated by sourceCDE
天津天士力之骄药业有限公司 CYHL2600098 Generic2026/09/16Not stated by sourceCDE
重庆宸安生物制药有限公司 CXSS2600147 New drug2026/09/07Not stated by sourceCDE
重庆宸安生物制药有限公司 CXSS2600146 New drug2026/09/07Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601574 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601573 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601572 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601571 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601570 Generic2026/07/02Not stated by sourceCDE
丽珠集团新北江制药股份有限公司 CXSS2600085 New drug2026/05/18Not stated by sourceCDE
丽珠集团新北江制药股份有限公司 CXSS2600084 New drug2026/05/18Not stated by sourceCDE
华润双鹤药业股份有限公司;深圳翰宇药业股份有限公司 CXHS2600064 New drug2026/05/08Not stated by sourceCDE
华润双鹤药业股份有限公司;深圳翰宇药业股份有限公司 CXHS2600063 New drug2026/05/08Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2600070 New drug2026/04/15Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2600069 New drug2026/04/15Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2600068 New drug2026/04/15Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2600067 New drug2026/04/15Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2600066 New drug2026/04/15Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600060 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600059 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600058 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600057 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600056 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600055 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600054 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600053 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600052 New drug2026/04/01Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2600051 New drug2026/04/01Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2600029 New drug2026/02/25Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2600028 New drug2026/02/25Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2600027 New drug2026/02/25Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2600026 New drug2026/02/25Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2600025 New drug2026/02/25Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500152 New drug2025/12/06Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500151 New drug2025/12/06Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500150 New drug2025/12/06Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500149 New drug2025/12/06Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500148 New drug2025/12/06Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2500089 New drug2025/09/03Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2500088 New drug2025/09/03Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2500087 New drug2025/09/03Not stated by sourceCDE
成都倍特生物制药有限公司 CXSS2500086 New drug2025/09/03Not stated by sourceCDE
惠升生物制药股份有限公司 CXSS2500084 New drug2025/08/16Not stated by sourceCDE
惠升生物制药股份有限公司 CXSS2500083 New drug2025/08/16Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500091 New drug2025/08/05Not stated by sourceCDE
石药集团百克(山东)生物制药股份有限公司;石药集团欧意药业有限公司 CXHS2500090 New drug2025/08/05Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2500043 New drug2025/04/03Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2500042 New drug2025/04/03Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2500041 New drug2025/04/03Not stated by sourceCDE
杭州中美华东制药江东有限公司 CXSS2500040 New drug2025/04/03Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2500009 New drug2025/01/24Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2500008 New drug2025/01/24Not stated by sourceCDE
齐鲁制药有限公司 CXHS2400095 New drug2024/09/15Not stated by sourceCDE
齐鲁制药有限公司 CXHS2400094 New drug2024/09/15Not stated by sourceCDE
丽珠集团新北江制药股份有限公司 CXSS2400059 New drug2024/06/13Not stated by sourceCDE
丽珠集团新北江制药股份有限公司 CXSS2400058 New drug2024/06/13Not stated by sourceCDE
丽珠集团新北江制药股份有限公司 CXSS2400057 New drug2024/06/13Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2400037 New drug2024/04/03Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2400036 New drug2024/04/03Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2400034 New drug2024/04/03Not stated by sourceCDE
杭州九源基因生物医药股份有限公司 CXSS2400032 New drug2024/04/03Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2600183 New drug2026/11/03Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2600182 New drug2026/11/03Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2600181 New drug2026/11/03Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2600180 New drug2026/11/03Not stated by sourceCDE
珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司 CXSS2600179 New drug2026/11/03Not stated by sourceCDE
New generic filings in 2026

Loaded records: 8 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
天津天士力之骄药业有限公司 CYHL2600100 Generic2026/09/16Not stated by sourceCDE
天津天士力之骄药业有限公司 CYHL2600099 Generic2026/09/16Not stated by sourceCDE
天津天士力之骄药业有限公司 CYHL2600098 Generic2026/09/16Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601574 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601573 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601572 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601571 Generic2026/07/02Not stated by sourceCDE
浙江三生蔓迪药业有限公司;深圳翰宇药业股份有限公司 CYHS2601570 Generic2026/07/02Not stated by sourceCDE
API registrations

Non-component matches: 0 companies with A status and 13 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
司美格鲁肽浙江湃肽生物股份有限公司Y20260000317IExact ingredient2026/04/23CDE
司美格鲁肽江苏诺泰澳赛诺生物制药股份有限公司Y20250001233IExact ingredient2026/03/16CDE
司美格鲁肽翰宇药业(武汉)有限公司Y20250001408IExact ingredient2026/01/16CDE
司美格鲁肽福建基诺厚普生物科技有限公司Y20250001109IExact ingredient2025/11/06CDE
司美格鲁肽山西同达药业有限公司Y20250000541IExact ingredient2025/07/11CDE
司美格鲁肽湖北健翔生物制药有限公司Y20250000636IExact ingredient2025/07/08CDE
司美格鲁肽福建基诺厚普生物科技有限公司Y20250000482IExact ingredient2025/05/30CDE
司美格鲁肽齐鲁制药有限公司Y20240000820IExact ingredient2024/09/02CDE
司美格鲁肽海南中和药业股份有限公司Y20240000122IExact ingredient2024/02/22CDE
司美格鲁肽湖北健翔生物制药有限公司Y20230000037IExact ingredient2023/02/16CDE
司美格鲁肽江苏诺泰澳赛诺生物制药股份有限公司Y20220001086IExact ingredient2023/01/10CDE
司美格鲁肽苏州天马医药集团天吉生物制药有限公司Y20220001169IExact ingredient2023/01/09CDE
司美格鲁肽苏州立新制药有限公司Y20260000766IExact ingredient2026/10/30CDE

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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

  1. 2026/11/03Accepted

    珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司

    CXSS2600183

    Fact date: 2026/11/03 · Site observation date: 2026/11/04

    View source ↗
  2. 2026/11/03Accepted

    珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司

    CXSS2600182

    Fact date: 2026/11/03 · Site observation date: 2026/11/04

    View source ↗
  3. 2026/11/03Accepted

    珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司

    CXSS2600181

    Fact date: 2026/11/03 · Site observation date: 2026/11/04

    View source ↗
  4. 2026/11/03Accepted

    珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司

    CXSS2600180

    Fact date: 2026/11/03 · Site observation date: 2026/11/04

    View source ↗
  5. 2026/11/03Accepted

    珠海联邦生物医药有限公司;珠海联邦制药股份有限公司中山分公司

    CXSS2600179

    Fact date: 2026/11/03 · Site observation date: 2026/11/04

    View source ↗
  6. 2026/10/20Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600022

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 27 ↗
  7. 2026/10/20Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600021

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 26 ↗
  8. 2026/10/20Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600020

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 25 ↗
  9. 2026/10/20Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600019

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 24 ↗
  10. 2026/10/20Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600018

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 23 ↗
  11. 2026/10/19Accepted

    广州白云山拜迪生物医药有限公司

    CXSL2601141

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  12. 2026/10/19Accepted

    广州白云山拜迪生物医药有限公司

    CXSL2601140

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  13. 2026/10/16Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600197

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 45 ↗
  14. 2026/10/16Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600196

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 44 ↗
  15. 2026/10/16Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600195

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 43 ↗
  16. 2026/10/16Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600194

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 42 ↗
  17. 2026/10/16Supplement delivery

    诺和诺德(中国)制药有限公司

    JYSB2600193

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 41 ↗
  18. 2026/09/24Accepted

    广州白云山拜迪生物医药有限公司;南京赛诺生物制药有限公司

    CXSL2601064

    Fact date: 2026/09/24 · Site observation date: 2026/10/21

    View source ↗
  19. 2026/09/24Accepted

    广州白云山拜迪生物医药有限公司;南京赛诺生物制药有限公司

    CXSL2601063

    Fact date: 2026/09/24 · Site observation date: 2026/10/21

    View source ↗
  20. 2026/09/16Accepted

    天津天士力之骄药业有限公司

    CYHL2600100

    Fact date: 2026/09/16 · Site observation date: 2026/10/22

    View source ↗
  21. 2026/09/16Accepted

    天津天士力之骄药业有限公司

    CYHL2600099

    Fact date: 2026/09/16 · Site observation date: 2026/10/22

    View source ↗
  22. 2026/09/16Accepted

    天津天士力之骄药业有限公司

    CYHL2600098

    Fact date: 2026/09/16 · Site observation date: 2026/10/22

    View source ↗
  23. 2026/09/07Accepted

    重庆宸安生物制药有限公司

    CXSS2600147

    Fact date: 2026/09/07 · Site observation date: 2026/10/22

    View source ↗
  24. 2026/09/07Accepted

    重庆宸安生物制药有限公司

    CXSS2600146

    Fact date: 2026/09/07 · Site observation date: 2026/10/22

    View source ↗
  25. 2026/08/17Accepted

    质肽药业(泰州)有限公司

    CXSS2600125

    Fact date: 2026/08/17 · Site observation date: 2026/10/21

    View source ↗
  26. 2026/08/17Accepted

    质肽药业(泰州)有限公司

    CXSS2600124

    Fact date: 2026/08/17 · Site observation date: 2026/10/21

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/10 07:27
Chemical-drug catalogue
Last successful update: 2026/11/10 07:23

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: 2026/11/10 07:25
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: 2026/11/10 18:31

First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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