Minocycline Hydrochloride Capsules

As of 13 November 2026, for Minocycline Hydrochloride Capsules, 19 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.

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

Listed in the US FDA Orange Book as MINOCIN (NDA 050649, BAUSCH HEALTH US LLC).

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 5 of 8 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: 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 name	Applicant (source text)	Application number	Dosage form (source text)	Route (source text)	Marketing status (source text)	Approval date
MINOCIN	BAUSCH HEALTH US LLC	NDA 050649 · Product no. 001, 002	CAPSULE	ORAL	HUMAN PRESCRIPTION DRUG	1990/05/31
MINOCIN	TRIAX PHARMACEUTICALS LLC	NDA 050315 · Product no. 001, 002	CAPSULE	ORAL	DISCONTINUED	Approved prior to 1982 (exact date not listed)
MINOCIN	BAUSCH HEALTH US LLC	NDA 050649 · Product no. 003	CAPSULE	ORAL	DISCONTINUED	2001/02/12

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
MINOCIN	REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC	NDA 050444 · Product no. 001	INJECTABLE	INJECTION	HUMAN PRESCRIPTION DRUG	Approved prior to 1982 (exact date not listed)
ARESTIN	ORAPHARMA INC	NDA 050781 · Product no. 001	POWDER, EXTENDED RELEASE	DENTAL	HUMAN PRESCRIPTION DRUG	2001/02/16
AMZEEQ	JOURNEY MEDICAL CORP	NDA 212379 · Product no. 001	AEROSOL, FOAM	TOPICAL	HUMAN PRESCRIPTION DRUG	2019/10/18
ZILXI	JOURNEY MEDICAL CORP	NDA 213690 · Product no. 001	AEROSOL, FOAM	TOPICAL	HUMAN PRESCRIPTION DRUG	2020/05/28
EMROSI	JOURNEY MEDICAL CORP	NDA 219015 · Product no. 001	CAPSULE, EXTENDED RELEASE	ORAL	HUMAN PRESCRIPTION DRUG	2024/11/01
MINOCIN	BAUSCH HEALTH US LLC	NDA 050445 · Product no. 001	SUSPENSION	ORAL	DISCONTINUED	Approved prior to 1982 (exact date not listed)

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 holders4View records ↓ Under-review filings19View records ↓ This year’s generic filers4View records ↓ NHSA approval numbers16View records ↓ API companies with A status6View records ↓

Chemical-drug catalogue

Loaded records: 4 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 2 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
Anhui Pioneer Pharmaceutical Co., Ltd	Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	2026/05/12	See source	Generic approved under the new chemical-drug registration classification	CDE
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized	Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized	国药准字H20264306	2026/05/12	See source	Generic approved under the new chemical-drug registration classification	CDE
Anhui Pioneer Pharmaceutical Co., Ltd	Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	2026/05/12	See source	Generic approved under the new chemical-drug registration classification	CDE
Haikou Shi Pharmaceutical Factory Co., Ltd. romanized	Haikou Shi Pharmaceutical Factory Co., Ltd. romanized	国药准字H10920124	2023/03/02	See source	Drug that passed quality-and-efficacy consistency evaluation	CDE
Name not romanized	Han Hui Pharmaceutical Co., Ltd. romanized	国药准字H20174080	1994/12/02	See source	Other drug	CDE
Name not romanized	Han Hui Pharmaceutical Co., Ltd. romanized	国药准字H20174081	1994/12/02	See source	Other 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: 16 distinct approval numbers and 13 companies.

Company / applicant	Approval number	Strength / specification	NHSA class	NHSA drug code	View source
Guangzhou Bai Yun Shan Guang Hua Pharmaceutical Co., Ltd. romanized	国药准字H44020434	See source	Category B	XJ01AAM106E001010100372	NHSA
Shenzhen Shi Zhong Lian Pharmaceutical Co., Ltd. romanized	国药准字H10940184	See source	Category B	XJ01AAM106E001010100543	NHSA
Shanghai Mei You Pharmaceutical Co., Ltd. romanized	国药准字H10950348	See source	Category B	XJ01AAM106E001010100727	NHSA
Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized	国药准字H10940285	See source	Category B	XJ01AAM106E001010101016	NHSA
NORTH CHINA PHARMACEUTICAL COMPANY.LTD	国药准字H20123310	50mg	Category B	XJ01AAM106E001010102690	NHSA
NORTH CHINA PHARMACEUTICAL COMPANY.LTD	国药准字H20010439	See source	Category B	XJ01AAM106E001010102697	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010104339	NHSA
Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized	国药准字H20083474	See source	Category B	XJ01AAM106E001010104436	NHSA
Kun Yao Group Co., Ltd. romanized	国药准字H10940017	See source	Category B	XJ01AAM106E001010105614	NHSA
Haikou Shi Pharmaceutical Factory Co., Ltd. romanized	国药准字H10920124	See source	Category B	XJ01AAM106E001010105758	NHSA
Han Hui Pharmaceutical Co., Ltd. romanized	国药准字H20174081	See source	Category B	XJ01AAM106E001010109853	NHSA
Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized	国药准字H20264306	See source	Category B	XJ01AAM106E001010182209	NHSA
Shanghai Mei You Pharmaceutical Co., Ltd. romanized	国药准字H10950348	See source	Category B	XJ01AAM106E001010200727	NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized	国药准字H20059110	See source	Category B	XJ01AAM106E001010201751	NHSA
NORTH CHINA PHARMACEUTICAL COMPANY.LTD	国药准字H20123310	50mg	Category B	XJ01AAM106E001010202690	NHSA
Ha Yao Group Pharmaceutical Liu Factory romanized	国药准字H10940059	50mg	Category B	XJ01AAM106E001010203711	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010204339	NHSA
Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized	国药准字H20083474	See source	Category B	XJ01AAM106E001010204436	NHSA
Haikou Shi Pharmaceutical Factory Co., Ltd. romanized	国药准字H10920124	See source	Category B	XJ01AAM106E001010205758	NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized	国药准字H20059110	See source	Category B	XJ01AAM106E001010301751	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010304339	NHSA
Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized	国药准字H20083474	See source	Category B	XJ01AAM106E001010304436	NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized	国药准字H20059110	See source	Category B	XJ01AAM106E001010401751	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010404339	NHSA
Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized	国药准字H20083474	See source	Category B	XJ01AAM106E001010404436	NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized	国药准字H20059110	See source	Category B	XJ01AAM106E001010501751	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010504339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010604339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010704339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010804339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001010904339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011004339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011104339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011204339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011304339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011404339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011504339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264293	See source	Category B	XJ01AAM106E001011604339	NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized	国药准字H20059110	See source	Category B	XJ01AAM106E001020101751	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020104339	NHSA
Haikou Shi Pharmaceutical Factory Co., Ltd. romanized	国药准字H10920124	See source	Category B	XJ01AAM106E001020105758	NHSA
Han Hui Pharmaceutical Co., Ltd. romanized	国药准字H20174080	See source	Category B	XJ01AAM106E001020109853	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020204339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020304339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020404339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020504339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020604339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020704339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020804339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001020904339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021004339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021104339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021204339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021304339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021404339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021504339	NHSA
Anhui Pioneer Pharmaceutical Co., Ltd	国药准字H20264292	See source	Category B	XJ01AAM106E001021604339	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: 19 filings and 11 distinct first applicants.

Supplement 4 · Generic 15

Current under-review applications
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
TC Pharmaceuticals (Jiangsu) Co., Ltd	CYHB2650007	Supplement	2026/01/07	Not stated by source	CDE
TC Pharmaceuticals (Jiangsu) Co., Ltd	CYHB2650006	Supplement	2026/01/07	Not stated by source	CDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTD	CYHB2650173	Supplement	2026/08/12	Not stated by source	CDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTD	CYHB2650172	Supplement	2026/08/12	Not stated by source	CDE
Zhejiang Innovation Bio Co., Ltd. romanized	CYHS2600462	Generic	2026/02/13	Not stated by source	CDE
Zhejiang Innovation Bio Co., Ltd. romanized	CYHS2600461	Generic	2026/02/13	Not stated by source	CDE
Shijiazhuang Kang Li Pharma Co., Ltd. romanized	CYHS2600307	Generic	2026/01/29	Not stated by source	CDE
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized	CYHS2600165	Generic	2026/01/13	Not stated by source	CDE
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized	CYHS2600164	Generic	2026/01/13	Not stated by source	CDE
Zhuhai Tong Yuan Pharma Co., Ltd. romanized	CYHS2600083	Generic	2026/01/08	Not stated by source	CDE
Zhuhai Tong Yuan Pharma Co., Ltd. romanized	CYHS2600082	Generic	2026/01/08	Not stated by source	CDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd	CYHS2503409	Generic	2025/09/16	Not stated by source	CDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd	CYHS2503408	Generic	2025/09/16	Not stated by source	CDE
Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized	CYHS2503324	Generic	2025/09/09	Not stated by source	CDE
Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized	CYHS2503323	Generic	2025/09/09	Not stated by source	CDE
Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Beijing Ya Bao Bio Pharma Co., Ltd. romanized	CYHS2503233	Generic	2025/09/02	Not stated by source	CDE
Hangzhou He Kang Pharma Co., Ltd. romanized	CYHS2501367	Generic	2025/04/09	Not stated by source	CDE
Hangzhou He Kang Pharma Co., Ltd. romanized	CYHS2501366	Generic	2025/04/09	Not stated by source	CDE
Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized	CYHS2500237	Generic	2025/01/10	Not stated by source	CDE

New generic filings in 2026

Loaded records: 7 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Zhejiang Innovation Bio Co., Ltd. romanized	CYHS2600462	Generic	2026/02/13	Not stated by source	CDE
Zhejiang Innovation Bio Co., Ltd. romanized	CYHS2600461	Generic	2026/02/13	Not stated by source	CDE
Shijiazhuang Kang Li Pharma Co., Ltd. romanized	CYHS2600307	Generic	2026/01/29	Not stated by source	CDE
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized	CYHS2600165	Generic	2026/01/13	Not stated by source	CDE
Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized	CYHS2600164	Generic	2026/01/13	Not stated by source	CDE
Zhuhai Tong Yuan Pharma Co., Ltd. romanized	CYHS2600083	Generic	2026/01/08	Not stated by source	CDE
Zhuhai Tong Yuan Pharma Co., Ltd. romanized	CYHS2600082	Generic	2026/01/08	Not stated by source	CDE

API registrations

Non-component matches: 6 companies with A status and 1 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
盐酸米诺环素 · No verified English name	Hai Zheng Pharma Nan Tong Co., Ltd. romanized	Y20240000032	A	Exact ingredient	2026/09/29	CDE
盐酸米诺环素 · No verified English name	HOVIONE FARMACIENCIA S.A.	Y20230000723	A	Exact ingredient	2025/10/14	CDE
盐酸米诺环素 · No verified English name	Zhejiang Chang Hai Pharmaceutical Co., Ltd. romanized	Y20220000076	A	Exact ingredient	2025/09/09	CDE
盐酸米诺环素 · No verified English name	CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A.	Y20210000751	A	Exact ingredient	2024/07/26	CDE
盐酸米诺环素 · No verified English name	HOVIONE FARMACIENCIA S.A.	Y20200000691	I	Exact ingredient	2020/08/03	CDE
盐酸米诺环素 · No verified English name	CURIA ITALY S.R.L.	Y20190008989	A	Exact ingredient	2026/09/03	CDE
盐酸米诺环素 · No verified English name	Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized	Y20190004294	A	Exact ingredient	2024/10/01	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 · 14-1

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