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Sign in to subscribeAs 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
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.
| Brand name | Applicant (source text) | Application number | Dosage 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) |
| Brand name | Applicant (source text) | Application number | Dosage 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.
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.
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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized | Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H20265949 | 2026/09/15 | 1ml:25mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H31021490 | 2026/08/11 | 1ml∶25mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20256394 | 2025/12/22 | 2ml:50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | Sui Cheng Pharma Co., Ltd. romanized | 国药准字H41021181 | 2025/08/07 | 2ml:50mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | 国药准字H21020328 | 2026/09/24 | 2ml:50mg | Drug that passed quality-and-efficacy consistency evaluation | 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.
Loaded records: 24 distinct approval numbers and 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H44021728 | 2ml:50mg | Category A | XR06ADY136B002010100267 | NHSA |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44022504 | 2ml:50mg | Category A | XR06ADY136B002010100315 | NHSA |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H31021490 | 1ml∶25mg | Category A | XR06ADY136B002010100673 | NHSA |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H12020969 | 2ml:50mg | Category A | XR06ADY136B002010100874 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50020140 | 2ml:50mg | Category A | XR06ADY136B002010100978 | NHSA |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | 国药准字H21020328 | 2ml:50mg | Category A | XR06ADY136B002010101157 | NHSA |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H32021437 | 1ml:25mg | Category A | XR06ADY136B002010101511 | NHSA |
| Hubei Ke Lun Pharma Co., Ltd. romanized | 国药准字H42021178 | 2ml:50mg | Category A | XR06ADY136B002010101871 | NHSA |
| Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 国药准字H42023002 | 2ml:50mg | Category A | XR06ADY136B002010101962 | NHSA |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H51023000 | 2ml:50mg | Category A | XR06ADY136B002010102065 | NHSA |
| Xian Feng Hua Pharma Co., Ltd. romanized | 国药准字H61021122 | 2ml:50mg | Category A | XR06ADY136B002010102420 | NHSA |
| Xian Di Sai Bio Pharma Co., Ltd. romanized | 国药准字H61021138 | 2ml:50mg | Category A | XR06ADY136B002010102470 | NHSA |
| Henan Fu Sen Pharma Co., Ltd. romanized | 国药准字H41021097 | 2ml:50mg | Category A | XR06ADY136B002010103020 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41020482 | 2ml:50mg | Category A | XR06ADY136B002010103098 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H41021181 | 2ml:50mg | Category A | XR06ADY136B002010103204 | NHSA |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H20053946 | 2ml:50mg | Category A | XR06ADY136B002010103377 | NHSA |
| Tong Hua Hua Xia Pharma Co., Ltd. romanized | 国药准字H20053042 | 2ml:50mg | Category A | XR06ADY136B002010103556 | NHSA |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H62020337 | 2ml:50mg | Category A | XR06ADY136B002010105868 | NHSA |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20256394 | 2ml:50mg | Category A | XR06ADY136B002010181161 | NHSA |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20266073 | 1ml:25mg | Category A | XR06ADY136B002010184300 | NHSA |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44022504 | 2ml:50mg | Category A | XR06ADY136B002010200315 | NHSA |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H31021490 | 1ml∶25mg | Category A | XR06ADY136B002010200673 | NHSA |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H12020969 | 2ml:50mg | Category A | XR06ADY136B002010200874 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50020140 | 2ml:50mg | Category A | XR06ADY136B002010200978 | NHSA |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | 国药准字H21020328 | 2ml:50mg | Category A | XR06ADY136B002010201157 | NHSA |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H32021437 | 1ml:25mg | Category A | XR06ADY136B002010201511 | NHSA |
| Hubei Ke Lun Pharma Co., Ltd. romanized | 国药准字H42021178 | 2ml:50mg | Category A | XR06ADY136B002010201871 | NHSA |
| Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 国药准字H42023002 | 2ml:50mg | Category A | XR06ADY136B002010201962 | NHSA |
| Henan Fu Sen Pharma Co., Ltd. romanized | 国药准字H41021097 | 2ml:50mg | Category A | XR06ADY136B002010203020 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41020482 | 2ml:50mg | Category A | XR06ADY136B002010203098 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H41021181 | 2ml:50mg | Category A | XR06ADY136B002010203204 | NHSA |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H20053946 | 2ml:50mg | Category A | XR06ADY136B002010203377 | NHSA |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H62020337 | 2ml:50mg | Category A | XR06ADY136B002010205868 | NHSA |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H31022033 | 2ml∶50mg | Category A | XR06ADY136B002020100673 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50021802 | 1ml:25mg | Category A | XR06ADY136B002020100978 | NHSA |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H32021438 | 2ml:50mg | Category A | XR06ADY136B002020101511 | NHSA |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20266074 | 2ml:50mg | Category A | XR06ADY136B002020184300 | NHSA |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H31022033 | 2ml∶50mg | Category A | XR06ADY136B002020200673 | NHSA |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H50021802 | 1ml:25mg | Category A | XR06ADY136B002020200978 | NHSA |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H32021438 | 2ml:50mg | Category A | XR06ADY136B002020201511 | 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.
Loaded records: 11 filings and 6 distinct first applicants.
Generic 11
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602131 | Generic | 2026/08/26 | Not stated by source | CDE |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602130 | Generic | 2026/08/26 | Not stated by source | CDE |
| Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | CYHS2601621 | Generic | 2026/07/07 | Not stated by source | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601244 | Generic | 2026/06/01 | Not stated by source | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601243 | Generic | 2026/06/01 | Not stated by source | CDE |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600442 | Generic | 2026/02/11 | Not stated by source | CDE |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600441 | Generic | 2026/02/11 | Not stated by source | CDE |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600044 | Generic | 2026/01/06 | Not stated by source | CDE |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600043 | Generic | 2026/01/06 | Not stated by source | CDE |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized | CYHS2503753 | Generic | 2025/10/21 | Not stated by source | CDE |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized | CYHS2503752 | Generic | 2025/10/21 | Not stated by source | CDE |
Loaded records: 9 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602131 | Generic | 2026/08/26 | Not stated by source | CDE |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602130 | Generic | 2026/08/26 | Not stated by source | CDE |
| Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | CYHS2601621 | Generic | 2026/07/07 | Not stated by source | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601244 | Generic | 2026/06/01 | Not stated by source | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601243 | Generic | 2026/06/01 | Not stated by source | CDE |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600442 | Generic | 2026/02/11 | Not stated by source | CDE |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600441 | Generic | 2026/02/11 | Not stated by source | CDE |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600044 | Generic | 2026/01/06 | Not stated by source | CDE |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600043 | Generic | 2026/01/06 | Not stated by source | CDE |
Non-component matches: 8 companies with A status and 8 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 |
|---|---|---|---|---|---|---|
| 盐酸异丙嗪 · No verified English name | Liao Yuan Shi Yin Ying Pharmaceutical Co., Ltd. romanized | Y20250001256 | I | Exact ingredient | 2025/12/03 | CDE |
| 盐酸异丙嗪 · No verified English name | Kang Pu Pharma Co., Ltd. romanized | Y20250001052 | I | Exact ingredient | 2025/10/15 | CDE |
| 盐酸异丙嗪 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20250001039 | I | Exact ingredient | 2025/10/11 | CDE |
| 盐酸异丙嗪 · No verified English name | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | Y20250000833 | I | Exact ingredient | 2025/08/18 | CDE |
| 盐酸异丙嗪 · No verified English name | Henan You Kai Pharmaceutical Co., Ltd. romanized | Y20250000406 | I | Exact ingredient | 2025/05/26 | CDE |
| 盐酸异丙嗪 · No verified English name | Sui Cheng Pharma Co., Ltd. romanized | Y20250000312 | A | Exact ingredient | 2026/10/30 | CDE |
| 盐酸异丙嗪 · No verified English name | Hebei Hua Chen Pharma Group Co., Ltd. romanized | Y20250000138 | A | Exact ingredient | 2026/11/04 | CDE |
| 盐酸异丙嗪 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000134 | A | Exact ingredient | 2026/06/24 | CDE |
| 盐酸异丙嗪 · No verified English name | EGIS PHARMACEUTICALS PLC | Y20200001368 | I | Exact ingredient | 2023/07/03 | CDE |
| 盐酸异丙嗪 · No verified English name | Dong Gang Shi Hong Da Pharmaceutical Co., Ltd. romanized | Y20190009610 | A | Exact ingredient | 2025/04/15 | CDE |
| 盐酸异丙嗪 · No verified English name | Liao Yuan Shi Di Kang Pharma Co., Ltd. romanized | Y20190005133 | A | Exact ingredient | 2025/05/07 | CDE |
| 盐酸异丙嗪 · No verified English name | Changzhou Kang Pu Pharma Co., Ltd. romanized | Y20190004404 | A | Exact ingredient | 2025/04/17 | CDE |
| 盐酸异丙嗪 · No verified English name | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190003815 | A | Exact ingredient | 2025/08/29 | CDE |
| 盐酸异丙嗪 · No verified English name | Dong Gang Shi Hong Da Pharmaceutical Co., Ltd. romanized | Y20180000801 | I | Exact ingredient | 2018/07/25 | CDE |
| 盐酸异丙嗪 · No verified English name | Harika Drugs Private Limited | Y20170001462 | I | Exact ingredient | — | CDE |
| 盐酸异丙嗪 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20170000888 | A | Exact ingredient | 2024/07/06 | 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.
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.
CYHS2602131
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗CYHS2602130
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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