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Matched- Active ingredients (original)
- PROMETHAZINE HYDROCHLORIDE
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approvalApproved before 1982
ANDA applications19
RLD applicantHIKMA PHARMACEUTICALS USA INC
Currently marketed products: 4 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A040372-001 | PROMETHAZINE HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2000/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A040372-002 | PROMETHAZINE HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | 2000/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A040454-001 | PROMETHAZINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2002/08/22 | N / N | DISCONTINUED | openFDA ↗ |
| A040454-002 | PROMETHAZINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2002/08/22 | N / N | DISCONTINUED | openFDA ↗ |
| A040471-001 | PROMETHAZINE HYDROCHLORIDE | MYLAN INSTITUTIONAL LLC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2002/11/21 | N / N | DISCONTINUED | openFDA ↗ |
| A040515-001 | PROMETHAZINE HYDROCHLORIDE | AMERICAN REGENT INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2003/03/19 | N / N | DISCONTINUED | openFDA ↗ |
| A040524-001 | PROMETHAZINE HYDROCHLORIDE | BEDFORD LABORATORIES | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2004/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A040524-002 | PROMETHAZINE HYDROCHLORIDE | BEDFORD LABORATORIES | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | 2004/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A040593-001 | PROMETHAZINE HYDROCHLORIDE | SANDOZ INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2006/11/08 | N / N | DISCONTINUED | openFDA ↗ |
| A040593-002 | PROMETHAZINE HYDROCHLORIDE | SANDOZ INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | 2006/11/08 | N / N | DISCONTINUED | openFDA ↗ |
| A040737-001 | PROMETHAZINE HYDROCHLORIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2008/04/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040737-002 | PROMETHAZINE HYDROCHLORIDE | XGEN PHARMACEUTICALS DJB INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | 2008/04/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040785-001 | PROMETHAZINE HYDROCHLORIDE | WOCKHARDT BIO AG | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 2008/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A040785-002 | PROMETHAZINE HYDROCHLORIDE | WOCKHARDT BIO AG | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | 2008/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A080629-002 | PROMETHAZINE HYDROCHLORIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083312-001 | PROMETHAZINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A083312-002 | PROMETHAZINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A083532-001 | PROMETHAZINE HYDROCHLORIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083532-002 | PROMETHAZINE HYDROCHLORIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083838-002 | PROMETHAZINE HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083955-001 | PROMETHAZINE HYDROCHLORIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083955-002 | PROMETHAZINE HYDROCHLORIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083997-001 | ZIPAN-25 | ALTANA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083997-002 | ZIPAN-50 | ALTANA INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084222-001 | PROMETHAZINE HYDROCHLORIDE | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084223-001 | PROMETHAZINE HYDROCHLORIDE | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084591-001 | PROMETHAZINE HYDROCHLORIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A089463-001 | PROMETHAZINE HYDROCHLORIDE | MARSAM PHARMACEUTICALS LLC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | 1988/05/02 | N / N | DISCONTINUED | openFDA ↗ |
| A089477-001 | PROMETHAZINE HYDROCHLORIDE | MARSAM PHARMACEUTICALS LLC | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | 1988/05/02 | N / N | DISCONTINUED | openFDA ↗ |
| N008857-002 | PHENERGAN | WYETH AYERST LABORATORIES | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 25MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N008857-003 | PHENERGAN | WYETH AYERST LABORATORIES | INJECTABLE | INJECTION | PROMETHAZINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. 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.
Catalog holders 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202659491ml：25mg | 2026/09/15 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310214901ml∶25mg | 2026/08/11 | Official source ↗ |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H202563942ml:50mg | 2025/12/22 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410211812ml：50mg | 2025/08/07 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | 国药准字H210203282ml：50mg | 2026/09/24 | Official source ↗ |
NHSA approval numbers 24
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H440217282ml:50mg | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H440225042ml:50mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310214901ml∶25mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120209692ml:50mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500201402ml:50mg | — | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | 国药准字H210203282ml:50mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320214371ml:25mg | — | Official source ↗ |
| Hubei Ke Lun Pharma Co., Ltd. romanized | 国药准字H420211782ml:50mg | — | Official source ↗ |
| Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 国药准字H420230022ml:50mg | — | Official source ↗ |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H510230002ml:50mg | — | Official source ↗ |
| Xian Feng Hua Pharma Co., Ltd. romanized | 国药准字H610211222ml:50mg | — | Official source ↗ |
| Xian Di Sai Bio Pharma Co., Ltd. romanized | 国药准字H610211382ml:50mg | — | Official source ↗ |
| Henan Fu Sen Pharma Co., Ltd. romanized | 国药准字H410210972ml:50mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H410204822ml:50mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410211812ml:50mg | — | Official source ↗ |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H200539462ml:50mg | — | Official source ↗ |
| Tong Hua Hua Xia Pharma Co., Ltd. romanized | 国药准字H200530422ml:50mg | — | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H620203372ml:50mg | — | Official source ↗ |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H202563942ml:50mg | — | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202660731ml:25mg | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H440225042ml:50mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310214901ml∶25mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120209692ml:50mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500201402ml:50mg | — | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | 国药准字H210203282ml:50mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320214371ml:25mg | — | Official source ↗ |
| Hubei Ke Lun Pharma Co., Ltd. romanized | 国药准字H420211782ml:50mg | — | Official source ↗ |
| Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 国药准字H420230022ml:50mg | — | Official source ↗ |
| Henan Fu Sen Pharma Co., Ltd. romanized | 国药准字H410210972ml:50mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H410204822ml:50mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410211812ml:50mg | — | Official source ↗ |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H200539462ml:50mg | — | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | 国药准字H620203372ml:50mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310220332ml∶50mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500218021ml:25mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320214382ml:50mg | — | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202660742ml:50mg | — | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | 国药准字H310220332ml∶50mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500218021ml:25mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320214382ml:50mg | — | Official source ↗ |
Under review 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602131 | 2026/08/26 | Official source ↗ |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602130 | 2026/08/26 | Official source ↗ |
| Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | CYHS2601621 | 2026/07/07 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601244 | 2026/06/01 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601243 | 2026/06/01 | Official source ↗ |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600442 | 2026/02/11 | Official source ↗ |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600441 | 2026/02/11 | Official source ↗ |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600044 | 2026/01/06 | Official source ↗ |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600043 | 2026/01/06 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized | CYHS2503753 | 2025/10/21 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized | CYHS2503752 | 2025/10/21 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602131 | 2026/08/26 | Official source ↗ |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Hebei Zhi Tong Biopharmaceutical Co., Ltd. romanized | CYHS2602130 | 2026/08/26 | Official source ↗ |
| Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | CYHS2601621 | 2026/07/07 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601244 | 2026/06/01 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | CYHS2601243 | 2026/06/01 | Official source ↗ |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600442 | 2026/02/11 | Official source ↗ |
| Heng Yan Biopharmaceuticals Technology (Xiamen) Co., Ltd. romanized; Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2600441 | 2026/02/11 | Official source ↗ |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600044 | 2026/01/06 | Official source ↗ |
| Kang Pu Pharma Co., Ltd. romanized | CYHS2600043 | 2026/01/06 | Official source ↗ |
API companies with A status 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sui Cheng Pharma Co., Ltd. romanized | Y20250000312 | 2026/10/30 | Official source ↗ |
| Hebei Hua Chen Pharma Group Co., Ltd. romanized | Y20250000138 | 2026/11/04 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000134 | 2026/06/24 | Official source ↗ |
| Dong Gang Shi Hong Da Pharmaceutical Co., Ltd. romanized | Y20190009610 | 2025/04/15 | Official source ↗ |
| Liao Yuan Shi Di Kang Pharma Co., Ltd. romanized | Y20190005133 | 2025/05/07 | Official source ↗ |
| Changzhou Kang Pu Pharma Co., Ltd. romanized | Y20190004404 | 2025/04/17 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190003815 | 2025/08/29 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | Y20170000888 | 2024/07/06 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Formulation crosswalk to INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-076. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 26-28 · 2019/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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