Montelukast Sodium Tablets

As of 13 November 2026, for Montelukast Sodium Tablets, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 12 holders.

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

Listed in the US FDA Orange Book as SINGULAIR (NDA 020829, ORGANON LLC A SUB OF ORGANON AND CO).

No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42

Current coverage may be incomplete

Follow for free

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

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 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: 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.

Same dosage form

Brand name	Applicant (source text)	Application number	Dosage form (source text)	Route (source text)	Marketing status (source text)	Approval date
SINGULAIR	ORGANON LLC A SUB OF ORGANON AND CO	NDA 020829 · Product no. 002	TABLET	ORAL	HUMAN PRESCRIPTION DRUG	1998/02/20

Other dosage forms of the same ingredient

Brand name	Applicant (source text)	Application number	Dosage form (source text)	Route (source text)	Marketing status (source text)	Approval date
SINGULAIR	ORGANON LLC A SUB OF ORGANON AND CO	NDA 020830 · Product no. 001	TABLET, CHEWABLE	ORAL	HUMAN PRESCRIPTION DRUG	1998/02/20
SINGULAIR	ORGANON LLC A SUB OF ORGANON AND CO	NDA 020830 · Product no. 002	TABLET, CHEWABLE	ORAL	DISCONTINUED	2000/03/03
SINGULAIR	ORGANON LLC A SUB OF ORGANON AND CO	NDA 021409 · Product no. 001	GRANULE	ORAL	DISCONTINUED	2002/07/26

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.

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	See source	Generic approved under the new chemical-drug registration classification	CDE
Zhejiang Nord Pharmaceutical Co., Ltd	Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	2025/06/10	See source	Generic approved under the new chemical-drug registration classification	CDE
Henan Bi Fu Pharmaceutical Co., Ltd. romanized	Henan Bi Fu Pharmaceutical Co., Ltd. romanized	国药准字H20249269	2024/11/05	See source	Generic approved under the new chemical-drug registration classification	CDE
Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized	Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized	国药准字H20244582	2024/07/30	See source	Not stated by source	CDE
Xin Dong Sheng Ji Co., Ltd. romanized	Xin Dong Sheng Ji Co., Ltd. romanized	国药准字HC20240003	2024/01/23	See source	Generic approved under the new chemical-drug registration classification	CDE
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	国药准字H20083372	2022/05/18	10mg	Drug that passed quality-and-efficacy consistency evaluation	CDE
Sandoz Private Limited	Sandoz Private Limited	国药准字HJ20210076	2021/11/03	See source	Generic approved under the new chemical-drug registration classification	CDE
Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized	Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized	国药准字H20064370	2021/04/13	See source	Drug that passed quality-and-efficacy consistency evaluation	CDE
Jiangsu Vanguard Pharmaceutical Co., Ltd.	Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	2020/07/16	See source	Generic approved under the new chemical-drug registration classification	CDE
CSPC OUYI PHARMACEUTICAL CO., LTD.	CSPC OUYI PHARMACEUTICAL CO., LTD.	国药准字H20203046	2020/02/20	See source	Generic approved under the new chemical-drug registration classification	CDE
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized	Hangzhou Min Sheng Bin Jiang Pharmaceutical Co., Ltd. romanized	国药准字H20183239	2018/07/06	See source	Generic approved under the new chemical-drug registration classification	CDE
Merck Sharp & Dohme B.V.	Merck Sharp & Dohme Ltd.	H20160473	1999/10/29	10mg	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.

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
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010101503	NHSA
Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized	国药准字H20064370	See source	Category B	XR03DCM082A001010102132	NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.	国药准字H20203046	See source	Category B	XR03DCM082A001010102770	NHSA
Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized	国药准字H20244582	See source	Category B	XR03DCM082A001010103818	NHSA
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	国药准字H20083372	10mg	Category B	XR03DCM082A001010104010	NHSA
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized	国药准字H20183239	See source	Category B	XR03DCM082A001010104494	NHSA
N.V. Organon	国药准字J20130047	10mg	Category B	XR03DCM082A001010178639	NHSA
Sandoz Private Limited	国药准字HJ20210076	See source	Category B	XR03DCM082A001010178809	NHSA
HETERO LABS LIMITED	国药准字HJ20250074	See source	Category B	XR03DCM082A001010179426	NHSA
Xin Dong Sheng Ji Co., Ltd. romanized	国药准字HC20240003	See source	Category B	XR03DCM082A001010182468	NHSA
Henan Bi Fu Pharmaceutical Co., Ltd. romanized	国药准字H20249269	See source	Category B	XR03DCM082A001010183004	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010183521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010201503	NHSA
Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized	国药准字H20064370	See source	Category B	XR03DCM082A001010202132	NHSA
Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized	国药准字H20244582	See source	Category B	XR03DCM082A001010203818	NHSA
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	国药准字H20083372	10mg	Category B	XR03DCM082A001010204010	NHSA
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized	国药准字H20183239	See source	Category B	XR03DCM082A001010204494	NHSA
N.V. Organon	国药准字J20130047	10mg	Category B	XR03DCM082A001010278639	NHSA
Sandoz Private Limited	国药准字HJ20210076	See source	Category B	XR03DCM082A001010278809	NHSA
Xin Dong Sheng Ji Co., Ltd. romanized	国药准字HC20240003	See source	Category B	XR03DCM082A001010282468	NHSA
Henan Bi Fu Pharmaceutical Co., Ltd. romanized	国药准字H20249269	See source	Category B	XR03DCM082A001010283004	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010283521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010301503	NHSA
Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized	国药准字H20064370	See source	Category B	XR03DCM082A001010302132	NHSA
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	国药准字H20083372	10mg	Category B	XR03DCM082A001010304010	NHSA
Henan Bi Fu Pharmaceutical Co., Ltd. romanized	国药准字H20249269	See source	Category B	XR03DCM082A001010383004	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010383521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010401503	NHSA
Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized	国药准字H20064370	See source	Category B	XR03DCM082A001010402132	NHSA
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	国药准字H20083372	10mg	Category B	XR03DCM082A001010404010	NHSA
Henan Bi Fu Pharmaceutical Co., Ltd. romanized	国药准字H20249269	See source	Category B	XR03DCM082A001010483004	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010483521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010501503	NHSA
Henan Bi Fu Pharmaceutical Co., Ltd. romanized	国药准字H20249269	See source	Category B	XR03DCM082A001010583004	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010583521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010601503	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010683521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010701503	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010783521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010801503	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010883521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001010901503	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001010983521	NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.	国药准字H20203308	See source	Category B	XR03DCM082A001011001503	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011083521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011183521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011283521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011383521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011483521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011583521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011683521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011783521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011883521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001011983521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012083521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012183521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012283521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012383521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012483521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012583521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012683521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012783521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012883521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001012983521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001013083521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001013183521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001013283521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001013383521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001013483521	NHSA
Zhejiang Nord Pharmaceutical Co., Ltd	国药准字H20254487	See source	Category B	XR03DCM082A001013583521	NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.	国药准字H20203046	See source	Category B	XR03DCM082A001020102770	NHSA
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized	国药准字H20183239	See source	Category B	XR03DCM082A001020104494	NHSA
N.V. Organon	国药准字HJ20181187	See source	Category B	XR03DCM082A001020179325	NHSA
N.V. Organon	国药准字HJ20181187	See source	Category B	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

Current under-review applications
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd.	CYHS2601037	Generic	2026/05/08	Not stated by source	CDE
Suzhou Yu Shi Pharma Co., Ltd. romanized	CYHS2600197	Generic	2026/01/16	Not stated by source	CDE
YaoPharma Co., Ltd.	CYHS2501613	Generic	2025/04/30	Not stated by source	CDE

New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd.	CYHS2601037	Generic	2026/05/08	Not stated by source	CDE
Suzhou Yu Shi Pharma Co., Ltd. romanized	CYHS2600197	Generic	2026/01/16	Not stated by source	CDE

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 · No verified English name	Morepen Laboratories Ltd,	Y20240000485	A	Exact ingredient	2026/06/23	CDE
孟鲁司特钠 · No verified English name	Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized	Y20240000834	A	Exact ingredient	2026/02/24	CDE
孟鲁司特钠 · No verified English name	Tian Ke (Jing Zhou) Pharmaceutical Co., Ltd. romanized	Y20240000602	A	Exact ingredient	2026/09/30	CDE
孟鲁司特钠 · No verified English name	Hetero Drugs Limited	Y20220000623	A	Exact ingredient	2025/06/24	CDE
孟鲁司特钠 · No verified English name	Di Jia Pharma Group Co., Ltd. romanized	Y20220000801	A	Exact ingredient	2024/09/07	CDE
孟鲁司特钠 · No verified English name	Matrix Pharmacorp Private Limited	Y20190021354	A	Exact ingredient	2026/09/05	CDE
孟鲁司特钠 · No verified English name	Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	Y20190009838	A	Exact ingredient	—	CDE
孟鲁司特钠 · No verified English name	Zhejiang Tian Yu Pharma Co., Ltd. romanized	Y20190009826	A	Exact ingredient	2023/03/24	CDE
孟鲁司特钠 · No verified English name	Morepen Laboratories Ltd.	Y20190009301	A	Exact ingredient	2025/01/06	CDE
孟鲁司特钠 · No verified English name	Unimark Remedies Limited	Y20190009208	A	Exact ingredient	2026/07/12	CDE
孟鲁司特钠 · No verified English name	Hanmi Fine Chemical Co., Ltd.	Y20190009191	A	Exact ingredient	—	CDE
孟鲁司特钠 · No verified English name	Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized	Y20190006234	A	Exact ingredient	2024/06/06	CDE
孟鲁司特钠 · No verified English name	Laurus Labs Limited, (Unit-1)	Y20190000825	I	Exact ingredient	2019/10/12	CDE
孟鲁司特钠 · No verified English name	Shandong Xin Shi Dai Pharma Co., Ltd. romanized	Y20190000411	A	Exact ingredient	2025/05/08	CDE
孟鲁司特钠 · No verified English name	MSN Pharmachem Private Limited	Y20190000103	A	Exact ingredient	2026/05/20	CDE
孟鲁司特钠 · No verified English name	Zhejiang Tian Yu Pharma Co., Ltd. romanized	Y20190000083	A	Exact ingredient	2026/03/05	CDE
孟鲁司特钠 · No verified English name	Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized	Y20170002051	I	Exact ingredient	—	CDE
孟鲁司特钠 · No verified English name	Shandong Xin Shi Dai Pharma Co., Ltd. romanized	Y20170001683	I	Exact ingredient	—	CDE
孟鲁司特钠 · No verified English name	Tai Yao Chemical Co., Ltd. romanized	Y20170001580	A	Exact ingredient	2022/09/05	CDE
孟鲁司特钠 · No verified English name	Shandong An Xin Pharmaceutical Co., Ltd. romanized	Y20170001337	A	Exact ingredient	2026/06/21	CDE
孟鲁司特钠 · No verified English name	Ai Mei Ke Jian (Zhongguo) Biopharmaceuticals Co., Ltd. romanized	Y20170000985	A	Exact ingredient	2024/04/30	CDE
孟鲁司特钠 · No verified English name	MSN PHARMACHEM PRIVATE LIMITED	Y20170000744	A	Exact ingredient	2024/12/31	CDE
孟鲁司特钠 · No verified English name	Kai Hui Pharma (Shanghai) Co., Ltd. romanized	Y20170000712	A	Exact ingredient	2022/11/08	CDE
孟鲁司特钠 · No verified English name	Guo Yao Group Zhi Jun (Suzhou) Pharmaceutical Co., Ltd. romanized	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: 2026/11/13 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.

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: 2026/11/13 06:42

Chemical-drug catalogue

Last successful update: 2026/11/13 06:39

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.

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.

About the Chinese official sources

These pages organize dated records from Chinese official sources. English drug labels use verified official primary names; original Chinese source names remain available in CSV exports.

CDE — The Center for Drug Evaluation lists application acceptances and applications currently under review.
CDE catalogue — The chemical-drug catalogue lists approvals, marketing authorisation holders and the original inclusion categories.
NHSA — The National Healthcare Security Administration maintains medicine codes, companies and approval numbers; its database is not an application decision register.
NMPA — The National Medical Products Administration publishes delivery notices for approval documents and notifications. Loaded notices do not cover all historical approvals.
CDE API registry — The active pharmaceutical ingredient registry lists registrations and their A/I association-review status.
Drug Clinical Trial Registry — Public registration numbers, applicants, first-publication dates and original classifications/phases. States are dated site observations; revisions are not continuously tracked.

Official English name source: NMPA reference-product directory, Shaanxi MPA republication · 27-349

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