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Promethazine Hydrochloride Injection

As of 13 November 2026, for Promethazine Hydrochloride Injection, 11 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 5 holders.

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

Last 90 days: Accepted: 2 applications

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 2 of 2 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: 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
PHENERGAN WYETH AYERST LABORATORIES NDA 008857 · Product no. 002, 003 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
PHENERGAN DELCOR ASSET CORP NDA 007935 · Product no. 002, 003, 004 TABLET ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)
PHENERGAN PHARMOBEDIENT CONSULTING LLC NDA 010926 · Product no. 001, 002 SUPPOSITORY RECTAL DISCONTINUED Approved prior to 1982 (exact date not listed)
PHENERGAN PHARMOBEDIENT CONSULTING LLC NDA 011689 · Product no. 001 SUPPOSITORY RECTAL DISCONTINUED Approved prior to 1982 (exact date not listed)
PROMETHAZINE HYDROCHLORIDE PLAIN ANI PHARMACEUTICALS INC NDA 008381 · Product no. 003 SYRUP ORAL DISCONTINUED Approved prior to 1982 (exact date not listed)
PROMETHAZINE HYDROCHLORIDE PLAIN ANI PHARMACEUTICALS INC NDA 008381 · Product no. 004 SYRUP ORAL DISCONTINUED 1984/04/18

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

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanizedYa Bang Pharmaceuticals Co., Ltd. romanized国药准字H202659492026/09/151ml:25mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai He Feng Pharmaceutical Co., Ltd. romanizedShanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310214902026/08/111ml∶25mgDrug that passed quality-and-efficacy consistency evaluationCDE
Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedYang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202563942025/12/222ml:50mgGeneric approved under the new chemical-drug registration classificationCDE
Sui Cheng Pharma Co., Ltd. romanizedSui Cheng Pharma Co., Ltd. romanized国药准字H410211812025/08/072ml:50mgDrug that passed quality-and-efficacy consistency evaluationCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedDan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210203282026/09/242ml:50mgDrug 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: 24 distinct approval numbers and 20 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized国药准字H440217282ml:50mgCategory AXR06ADY136B002010100267NHSA
Guangdong Nan Guo Pharma Co., Ltd. romanized国药准字H440225042ml:50mgCategory AXR06ADY136B002010100315NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310214901ml∶25mgCategory AXR06ADY136B002010100673NHSA
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H120209692ml:50mgCategory AXR06ADY136B002010100874NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500201402ml:50mgCategory AXR06ADY136B002010100978NHSA
Dan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210203282ml:50mgCategory AXR06ADY136B002010101157NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H320214371ml:25mgCategory AXR06ADY136B002010101511NHSA
Hubei Ke Lun Pharma Co., Ltd. romanized国药准字H420211782ml:50mgCategory AXR06ADY136B002010101871NHSA
Wuhan Fu Xing Bio Pharma Co., Ltd. romanized国药准字H420230022ml:50mgCategory AXR06ADY136B002010101962NHSA
Chengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H510230002ml:50mgCategory AXR06ADY136B002010102065NHSA
Xian Feng Hua Pharma Co., Ltd. romanized国药准字H610211222ml:50mgCategory AXR06ADY136B002010102420NHSA
Xian Di Sai Bio Pharma Co., Ltd. romanized国药准字H610211382ml:50mgCategory AXR06ADY136B002010102470NHSA
Henan Fu Sen Pharma Co., Ltd. romanized国药准字H410210972ml:50mgCategory AXR06ADY136B002010103020NHSA
Topfond Pharmaceutical Co., Ltd.国药准字H410204822ml:50mgCategory AXR06ADY136B002010103098NHSA
Sui Cheng Pharma Co., Ltd. romanized国药准字H410211812ml:50mgCategory AXR06ADY136B002010103204NHSA
Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized国药准字H200539462ml:50mgCategory AXR06ADY136B002010103377NHSA
Tong Hua Hua Xia Pharma Co., Ltd. romanized国药准字H200530422ml:50mgCategory AXR06ADY136B002010103556NHSA
Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized国药准字H620203372ml:50mgCategory AXR06ADY136B002010105868NHSA
Yang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202563942ml:50mgCategory AXR06ADY136B002010181161NHSA
Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized国药准字H202660731ml:25mgCategory AXR06ADY136B002010184300NHSA
Guangdong Nan Guo Pharma Co., Ltd. romanized国药准字H440225042ml:50mgCategory AXR06ADY136B002010200315NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310214901ml∶25mgCategory AXR06ADY136B002010200673NHSA
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H120209692ml:50mgCategory AXR06ADY136B002010200874NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500201402ml:50mgCategory AXR06ADY136B002010200978NHSA
Dan Dong Yi Chuang Pharma Co., Ltd. romanized国药准字H210203282ml:50mgCategory AXR06ADY136B002010201157NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H320214371ml:25mgCategory AXR06ADY136B002010201511NHSA
Hubei Ke Lun Pharma Co., Ltd. romanized国药准字H420211782ml:50mgCategory AXR06ADY136B002010201871NHSA
Wuhan Fu Xing Bio Pharma Co., Ltd. romanized国药准字H420230022ml:50mgCategory AXR06ADY136B002010201962NHSA
Henan Fu Sen Pharma Co., Ltd. romanized国药准字H410210972ml:50mgCategory AXR06ADY136B002010203020NHSA
Topfond Pharmaceutical Co., Ltd.国药准字H410204822ml:50mgCategory AXR06ADY136B002010203098NHSA
Sui Cheng Pharma Co., Ltd. romanized国药准字H410211812ml:50mgCategory AXR06ADY136B002010203204NHSA
Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized国药准字H200539462ml:50mgCategory AXR06ADY136B002010203377NHSA
Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized国药准字H620203372ml:50mgCategory AXR06ADY136B002010205868NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310220332ml∶50mgCategory AXR06ADY136B002020100673NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500218021ml:25mgCategory AXR06ADY136B002020100978NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H320214382ml:50mgCategory AXR06ADY136B002020101511NHSA
Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized国药准字H202660742ml:50mgCategory AXR06ADY136B002020184300NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310220332ml∶50mgCategory AXR06ADY136B002020200673NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500218021ml:25mgCategory AXR06ADY136B002020200978NHSA
Ya Bang Pharmaceuticals Co., Ltd. romanized国药准字H320214382ml:50mgCategory AXR06ADY136B002020201511NHSA

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 6 distinct first applicants.

Generic 11

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanizedCYHS2602131Generic2026/08/26Not stated by sourceCDE
Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanizedCYHS2602130Generic2026/08/26Not stated by sourceCDE
Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanizedCYHS2601621Generic2026/07/07Not stated by sourceCDE
Ya Bao Pharma Group Co., Ltd. romanizedCYHS2601244Generic2026/06/01Not stated by sourceCDE
Ya Bao Pharma Group Co., Ltd. romanizedCYHS2601243Generic2026/06/01Not stated by sourceCDE
Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanizedCYHS2600442Generic2026/02/11Not stated by sourceCDE
Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanizedCYHS2600441Generic2026/02/11Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2600044Generic2026/01/06Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2600043Generic2026/01/06Not stated by sourceCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanizedCYHS2503753Generic2025/10/21Not stated by sourceCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanizedCYHS2503752Generic2025/10/21Not stated by sourceCDE
New generic filings in 2026

Loaded records: 9 filings and 5 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanizedCYHS2602131Generic2026/08/26Not stated by sourceCDE
Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanizedCYHS2602130Generic2026/08/26Not stated by sourceCDE
Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanizedCYHS2601621Generic2026/07/07Not stated by sourceCDE
Ya Bao Pharma Group Co., Ltd. romanizedCYHS2601244Generic2026/06/01Not stated by sourceCDE
Ya Bao Pharma Group Co., Ltd. romanizedCYHS2601243Generic2026/06/01Not stated by sourceCDE
Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanizedCYHS2600442Generic2026/02/11Not stated by sourceCDE
Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanizedCYHS2600441Generic2026/02/11Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2600044Generic2026/01/06Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2600043Generic2026/01/06Not stated by sourceCDE
API registrations

Non-component matches: 8 companies with A status and 8 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸异丙嗪 · No verified English nameLiao Yuan Shi Yin Ying Pharmaceutical Co., Ltd. romanizedY20250001256IExact ingredient2025/12/03CDE
盐酸异丙嗪 · No verified English nameKang Pu Pharma Co., Ltd. romanizedY20250001052IExact ingredient2025/10/15CDE
盐酸异丙嗪 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20250001039IExact ingredient2025/10/11CDE
盐酸异丙嗪 · No verified English nameBai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanizedY20250000833IExact ingredient2025/08/18CDE
盐酸异丙嗪 · No verified English nameHenan You Kai Pharmaceutical Co., Ltd. romanizedY20250000406IExact ingredient2025/05/26CDE
盐酸异丙嗪 · No verified English nameSui Cheng Pharma Co., Ltd. romanizedY20250000312AExact ingredient2026/10/30CDE
盐酸异丙嗪 · No verified English nameHebei Hua Chen Pharma Group Co., Ltd. romanizedY20250000138AExact ingredient2026/11/04CDE
盐酸异丙嗪 · No verified English nameYun Peng Pharmaceuticals Group Co., Ltd. romanizedY20250000134AExact ingredient2026/06/24CDE
盐酸异丙嗪 · No verified English nameEGIS PHARMACEUTICALS PLCY20200001368IExact ingredient2023/07/03CDE
盐酸异丙嗪 · No verified English nameDong Gang Shi Hong Da Pharmaceutical Co., Ltd. romanizedY20190009610AExact ingredient2025/04/15CDE
盐酸异丙嗪 · No verified English nameLiao Yuan Shi Di Kang Pharma Co., Ltd. romanizedY20190005133AExact ingredient2025/05/07CDE
盐酸异丙嗪 · No verified English nameChangzhou Kang Pu Pharma Co., Ltd. romanizedY20190004404AExact ingredient2025/04/17CDE
盐酸异丙嗪 · No verified English nameDan Dong Yi Chuang Pharma Co., Ltd. romanizedY20190003815AExact ingredient2025/08/29CDE
盐酸异丙嗪 · No verified English nameDong Gang Shi Hong Da Pharmaceutical Co., Ltd. romanizedY20180000801IExact ingredient2018/07/25CDE
盐酸异丙嗪 · No verified English nameHarika Drugs Private LimitedY20170001462IExact ingredient—CDE
盐酸异丙嗪 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20170000888AExact ingredient2024/07/06CDE

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. 2026/08/26Accepted

    Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized

    CYHS2602131

    Fact date: 2026/08/26 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/08/26Accepted

    Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized

    CYHS2602130

    Fact date: 2026/08/26 · Site observation date: 2026/10/22

    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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