Monthly
US$200
Billed every month
Montelukast Sodium Tablets(孟鲁司特钠片)
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: 2026/11/10 07:27
Current coverage may be incomplete
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.
Catalogue holders12View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers13View records ↓
API companies with A status20View records ↓
Chemical-drug catalogue
Loaded records: 12 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 8 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 |
|---|---|---|---|---|---|---|
| HETERO LABS LIMITED | HETERO LABS LIMITED | 国药准字HJ20250074 | 2025/06/24 | 10mg（按C35H36ClNO3S计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江诺得药业有限公司 | 浙江诺得药业有限公司 | 国药准字H20254487 | 2025/06/10 | 10mg（按C35H36ClNO3S计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 河南比福制药股份有限公司 | 河南比福制药股份有限公司 | 国药准字H20249269 | 2024/11/05 | 10mg（按C35H36ClNO3S计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 牡丹江恒远药业股份有限公司 | 浙江赛默制药有限公司 | 国药准字H20244582 | 2024/07/30 | 10mg（以孟鲁司特计） | Not stated by source | CDE |
| 信东生技股份有限公司 | 信东生技股份有限公司 | 国药准字HC20240003 | 2024/01/23 | 10mg（以孟鲁司特计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 鲁南贝特制药有限公司 | 鲁南贝特制药有限公司 | 国药准字H20083372 | 2022/05/18 | 10mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| Sandoz Private Limited | Sandoz Private Limited | 国药准字HJ20210076 | 2021/11/03 | 10mg（以孟鲁司特计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川大冢制药有限公司 | 四川大冢制药有限公司 | 国药准字H20064370 | 2021/04/13 | 10mg(按孟鲁司特计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20203308 | 2020/07/16 | 10mg（以孟鲁司特计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 石药集团欧意药业有限公司 | 石药集团欧意药业有限公司 | 国药准字H20203046 | 2020/02/20 | 10mg(按C35H36ClNO3S计) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 上海安必生制药技术有限公司 | 杭州民生滨江制药有限公司 | 国药准字H20183239 | 2018/07/06 | 10mg（以孟鲁司特计） | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| Merck Sharp & Dohme B.V. | Merck Sharp & Dohme Ltd. | H20160473 | 1999/10/29 | 10mg | Imported originator drug (进口原研药品) | 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.
NHSA drug codes
Loaded records: 13 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010101503 | NHSA |
| 四川大冢制药有限公司 | 国药准字H20064370 | 10mg(按孟鲁司特计) | Category B (乙) | XR03DCM082A001010102132 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20203046 | 10mg(按C35H36ClNO3S计) | Category B (乙) | XR03DCM082A001010102770 | NHSA |
| 牡丹江恒远药业股份有限公司 | 国药准字H20244582 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010103818 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20083372 | 10mg | Category B (乙) | XR03DCM082A001010104010 | NHSA |
| 上海安必生制药技术有限公司 | 国药准字H20183239 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010104494 | NHSA |
| N.V. Organon | 国药准字J20130047 | 10mg | Category B (乙) | XR03DCM082A001010178639 | NHSA |
| Sandoz Private Limited | 国药准字HJ20210076 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010178809 | NHSA |
| HETERO LABS LIMITED | 国药准字HJ20250074 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010179426 | NHSA |
| 信东生技股份有限公司 | 国药准字HC20240003 | 10mg(按孟鲁司特计) | Category B (乙) | XR03DCM082A001010182468 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249269 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010183004 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010183521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010201503 | NHSA |
| 四川大冢制药有限公司 | 国药准字H20064370 | 10mg(按孟鲁司特计) | Category B (乙) | XR03DCM082A001010202132 | NHSA |
| 牡丹江恒远药业股份有限公司 | 国药准字H20244582 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010203818 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20083372 | 10mg | Category B (乙) | XR03DCM082A001010204010 | NHSA |
| 上海安必生制药技术有限公司 | 国药准字H20183239 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010204494 | NHSA |
| N.V. Organon | 国药准字J20130047 | 10mg | Category B (乙) | XR03DCM082A001010278639 | NHSA |
| Sandoz Private Limited | 国药准字HJ20210076 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010278809 | NHSA |
| 信东生技股份有限公司 | 国药准字HC20240003 | 10mg(按孟鲁司特计) | Category B (乙) | XR03DCM082A001010282468 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249269 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010283004 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010283521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010301503 | NHSA |
| 四川大冢制药有限公司 | 国药准字H20064370 | 10mg(按孟鲁司特计) | Category B (乙) | XR03DCM082A001010302132 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20083372 | 10mg | Category B (乙) | XR03DCM082A001010304010 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249269 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010383004 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010383521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010401503 | NHSA |
| 四川大冢制药有限公司 | 国药准字H20064370 | 10mg(按孟鲁司特计) | Category B (乙) | XR03DCM082A001010402132 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20083372 | 10mg | Category B (乙) | XR03DCM082A001010404010 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249269 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010483004 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010483521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010501503 | NHSA |
| 河南比福制药股份有限公司 | 国药准字H20249269 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010583004 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010583521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010601503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010683521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010701503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010783521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010801503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010883521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001010901503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001010983521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20203308 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001011001503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001011983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001012983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001013083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001013183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001013283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001013383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001013483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20254487 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001013583521 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20203046 | 10mg(按C35H36ClNO3S计) | Category B (乙) | XR03DCM082A001020102770 | NHSA |
| 上海安必生制药技术有限公司 | 国药准字H20183239 | 10mg(以孟鲁司特计) | Category B (乙) | XR03DCM082A001020104494 | NHSA |
| N.V. Organon | 国药准字HJ20181187 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001020179325 | NHSA |
| N.V. Organon | 国药准字HJ20181187 | 10mg(按C₃₅H₃₆ClNO₃S计) | Category B (乙) | XR03DCM082A001020279325 | 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.
Current under-review applications
Loaded records: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海南万玮制药有限公司;江苏万高药业股份有限公司 | CYHS2601037 | Generic | 2026/05/08 | Not stated by source | CDE |
| 苏州俞氏药业有限公司 | CYHS2600197 | Generic | 2026/01/16 | Not stated by source | CDE |
| 重庆药友制药有限责任公司 | CYHS2501613 | Generic | 2025/04/30 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 20 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 孟鲁司特钠 | Morepen Laboratories Ltd, | Y20240000485 | A | Exact ingredient | 2026/06/23 | CDE |
| 孟鲁司特钠 | 江苏正大丰海制药有限公司 | Y20240000834 | A | Exact ingredient | 2026/02/24 | CDE |
| 孟鲁司特钠 | 天科（荆州）制药有限公司 | Y20240000602 | A | Exact ingredient | 2026/09/30 | CDE |
| 孟鲁司特钠 | Hetero Drugs Limited | Y20220000623 | A | Exact ingredient | 2025/06/24 | CDE |
| 孟鲁司特钠 | 迪嘉药业集团股份有限公司 | Y20220000801 | A | Exact ingredient | 2024/09/07 | CDE |
| 孟鲁司特钠 | Matrix Pharmacorp Private Limited | Y20190021354 | A | Exact ingredient | 2026/09/05 | CDE |
| 孟鲁司特钠 | 鲁南贝特制药有限公司 | Y20190009838 | A | Exact ingredient | — | CDE |
| 孟鲁司特钠 | 浙江天宇药业股份有限公司 | Y20190009826 | A | Exact ingredient | 2023/03/24 | CDE |
| 孟鲁司特钠 | Morepen Laboratories Ltd. | Y20190009301 | A | Exact ingredient | 2025/01/06 | CDE |
| 孟鲁司特钠 | Unimark Remedies Limited | Y20190009208 | A | Exact ingredient | 2026/07/12 | CDE |
| 孟鲁司特钠 | Hanmi Fine Chemical Co., Ltd. | Y20190009191 | A | Exact ingredient | — | CDE |
| 孟鲁司特钠 | 牡丹江恒远药业股份有限公司 | Y20190006234 | A | Exact ingredient | 2024/06/06 | CDE |
| 孟鲁司特钠 | Laurus Labs Limited, (Unit-1) | Y20190000825 | I | Exact ingredient | 2019/10/12 | CDE |
| 孟鲁司特钠 | 山东新时代药业有限公司 | Y20190000411 | A | Exact ingredient | 2025/05/08 | CDE |
| 孟鲁司特钠 | MSN Pharmachem Private Limited | Y20190000103 | A | Exact ingredient | 2026/05/20 | CDE |
| 孟鲁司特钠 | 浙江天宇药业股份有限公司 | Y20190000083 | A | Exact ingredient | 2026/03/05 | CDE |
| 孟鲁司特钠 | 鲁南贝特制药有限公司 | Y20170002051 | I | Exact ingredient | — | CDE |
| 孟鲁司特钠 | 山东新时代药业有限公司 | Y20170001683 | I | Exact ingredient | — | CDE |
| 孟鲁司特钠 | 台耀化学股份有限公司 | Y20170001580 | A | Exact ingredient | 2022/09/05 | CDE |
| 孟鲁司特钠 | 山东安信制药有限公司 | Y20170001337 | A | Exact ingredient | 2026/06/21 | CDE |
| 孟鲁司特钠 | 艾美科健（中国）生物医药有限公司 | Y20170000985 | A | Exact ingredient | 2024/04/30 | CDE |
| 孟鲁司特钠 | MSN PHARMACHEM PRIVATE LIMITED | Y20170000744 | A | Exact ingredient | 2024/12/31 | CDE |
| 孟鲁司特钠 | 凯惠药业（上海）有限公司 | Y20170000712 | A | Exact ingredient | 2022/11/08 | CDE |
| 孟鲁司特钠 | 国药集团致君（苏州）制药有限公司 | Y20170000709 | A | Exact ingredient | 2022/09/30 | 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.
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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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