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Doxycycline Hyclate for Injection

As of 13 November 2026, for Doxycycline Hyclate for Injection, 11 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 3 holders.

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

Last 90 days: Accepted: 3 applicationsNo longer listed under review: 1 application

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 5 of 9 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: for Injection. 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
VIBRAMYCIN PFIZER LABORATORIES DIV PFIZER INC NDA 050442 · Product no. 001, 002 INJECTABLE INJECTION DISCONTINUED Approved prior to 1982 (exact date not listed)

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
ACTICLATE CHARTWELL RX SCIENCES LLC NDA 205931 · Product no. 001, 002 TABLET ORAL HUMAN PRESCRIPTION DRUG 2014/07/25
DORYX MPC MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050795 · Product no. 007 TABLET, DELAYED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2016/05/20
VIBRA-TABS PFIZER LABORATORIES DIV PFIZER INC NDA 050533 · Product no. 001 TABLET ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)
VIBRAMYCIN PFIZER LABORATORIES DIV PFIZER INC NDA 050007 · Product no. 001, 002 CAPSULE ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)
DORYX MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050582 · Product no. 001 CAPSULE, DELAYED RELEASE ORAL DISCONTINUED 1985/07/22
DORYX MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050582 · Product no. 002 CAPSULE, DELAYED RELEASE ORAL DISCONTINUED 2001/08/13
DORYX MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050795 · Product no. 001, 002 TABLET, DELAYED RELEASE ORAL DISCONTINUED 2005/05/06
DORYX MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050795 · Product no. 003 TABLET, DELAYED RELEASE ORAL DISCONTINUED 2008/06/20
DORYX MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050795 · Product no. 004, 005 TABLET, DELAYED RELEASE ORAL DISCONTINUED 2013/04/11
DORYX MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050795 · Product no. 006 TABLET, DELAYED RELEASE ORAL DISCONTINUED 2014/12/19
DORYX MPC MAYNE PHARMA INTERNATIONAL PTY LTD NDA 050795 · Product no. 008 TABLET, DELAYED RELEASE ORAL DISCONTINUED 2016/05/20

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: 3 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 1 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedHainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202495762024/12/010.1gGeneric approved under the new chemical-drug registration classificationCDE
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedHainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H202495772024/12/010.2gGeneric approved under the new chemical-drug registration classificationCDE
Haikou Qi Li Pharmaceutical Co., Ltd. romanizedHaikou Qi Li Pharmaceutical Co., Ltd. romanized国药准字H200806302024/04/29See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanizedHainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H200604052023/04/21See sourceDrug that passed quality-and-efficacy consistency evaluationCDE

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: 8 distinct approval numbers and 5 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized国药准字H20051974See sourceCategory BXJ01AAD193B001010100348NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20193375See sourceCategory BXJ01AAD193B001010103421NHSA
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H20060405See sourceCategory BXJ01AAD193B001010105754NHSA
Hainan Ying Da Run Ze Pharma Co., Ltd. romanized国药准字H20080630See sourceCategory BXJ01AAD193B001010105755NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20249576See sourceCategory BXJ01AAD193B001010105801NHSA
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized国药准字H20051974See sourceCategory BXJ01AAD193B001010200348NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20193376See sourceCategory BXJ01AAD193B001010203421NHSA
Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized国药准字H20060405See sourceCategory BXJ01AAD193B001010205754NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20249576See sourceCategory BXJ01AAD193B001010205801NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20193375See sourceCategory BXJ01AAD193B001010303421NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20193376See sourceCategory BXJ01AAD193B001010403421NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20193375See sourceCategory BXJ01AAD193B001010503421NHSA
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized国药准字H20193376See sourceCategory BXJ01AAD193B001010603421NHSA
Hainan Ying Da Run Ze Pharma Co., Ltd. romanized国药准字H20080631See sourceCategory BXJ01AAD193B001020105755NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20249577See sourceCategory BXJ01AAD193B001020105801NHSA
Hainan Pu Li Pharmaceutical Co., Ltd. romanized国药准字H20249577See sourceCategory BXJ01AAD193B001020205801NHSA

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: 11 filings and 8 distinct first applicants.

Generic 8 · Supplement 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanizedCYHS2502839Generic2025/08/06Not stated by sourceCDE
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS2602083Generic2026/08/21Not stated by sourceCDE
Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCYHS2501777Generic2025/05/16Not stated by sourceCDE
Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHB2601761Supplement2026/09/18Not stated by sourceCDE
Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHB2601760Supplement2026/09/18Not stated by sourceCDE
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanizedCYHB2650083Supplement2026/03/23Not stated by sourceCDE
Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanizedCYHS2600321Generic2026/01/31Not stated by sourceCDE
Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanizedCYHS2600319Generic2026/01/31Not stated by sourceCDE
Hubei Mei Lin Pharma Co., Ltd. romanizedCYHS2503467Generic2025/09/19Not stated by sourceCDE
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2502665Generic2025/07/23Not stated by sourceCDE
Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2502663Generic2025/07/23Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS2602083Generic2026/08/21Not stated by sourceCDE
Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanizedCYHS2600321Generic2026/01/31Not stated by sourceCDE
Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanizedCYHS2600319Generic2026/01/31Not stated by sourceCDE
API registrations

Non-component matches: 12 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸多西环素 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20240001089AExact ingredient2026/08/15CDE
多西环素 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20240000584ISalt-normalized ingredient2024/08/21CDE
盐酸多西环素 · No verified English nameHOVIONE PHARMASCIENCE LIMITEDY20220000451AExact ingredient2026/05/20CDE
盐酸多西环素 · No verified English nameShanghai Qing Ping Pharma Co., Ltd. romanizedY20190006582AExact ingredient2026/01/31CDE
盐酸多西环素 · No verified English nameKun Shandong Fang Pharma Co., Ltd. romanizedY20190006560AExact ingredient—CDE
盐酸多西环素 · No verified English nameShijiazhuang Hua Shu Shan He Pharma Co., Ltd. romanizedY20190006021AExact ingredient—CDE
盐酸多西环素 · No verified English nameHebei Dong Feng Pharma Co., Ltd. romanizedY20190005098AExact ingredient2025/02/09CDE
盐酸多西环素 · No verified English nameSuzhou Di Wu Pharmaceutical Factory Co., Ltd. romanizedY20190005068AExact ingredient—CDE
盐酸多西环素 · No verified English nameYan Cheng Su Hai Pharmaceutical Co., Ltd. romanizedY20190004892AExact ingredient2025/07/18CDE
盐酸多西环素 · No verified English nameChangzhou Pharmaceutical Factory Co., Ltd. romanizedY20190004505AExact ingredient2025/07/09CDE
盐酸多西环素 · No verified English nameJiangsu Lianhuan Pharmaceutical Co.,Ltd.Y20190004072AExact ingredient2025/07/30CDE
盐酸多西环素 · No verified English nameKai Feng Pharmaceutical (Group) Co., Ltd. romanizedY20190002589AExact ingredient2024/09/11CDE
盐酸多西环素 · No verified English nameShandong Lukang Pharmaceutical Co.,Ltd.Y20190002114AExact ingredient2025/01/23CDE

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. 2026/11/06No longer listed under review

    Hainan Brilliant Pharmaceutical Co., Ltd.

    CYHS2501092

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2025/03/18

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/09/18Accepted
  3. 2026/09/18Accepted
  4. 2026/08/21Accepted

    Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized

    CYHS2602083

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

    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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