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Sign in to subscribeHydrocortisone Sodium Succinate for Injection
Matched- Active ingredients (original)
- HYDROCORTISONE SODIUM SUCCINATE
- 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 applications27
RLD applicantPHARMACIA AND UPJOHN CO
Currently marketed products: 7 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A040666-001 | A-HYDROCORT | HOSPIRA INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 2006/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A084737-001 | HYDROCORTISONE SODIUM SUCCINATE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 250MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084737-002 | HYDROCORTISONE SODIUM SUCCINATE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084738-001 | HYDROCORTISONE SODIUM SUCCINATE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084747-001 | HYDROCORTISONE SODIUM SUCCINATE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084748-001 | HYDROCORTISONE SODIUM SUCCINATE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A085928-001 | A-HYDROCORT | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A085929-001 | A-HYDROCORT | HOSPIRA INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A085930-001 | A-HYDROCORT | HOSPIRA WORLDWIDE, INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 250MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A085931-001 | A-HYDROCORT | HOSPIRA WORLDWIDE, INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A085932-001 | A-HYDROCORT | HOSPIRA WORLDWIDE, INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A086619-001 | HYDROCORTISONE SODIUM SUCCINATE | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A087532-001 | HYDROCORTISONE SODIUM SUCCINATE | INTERNATIONAL MEDICATION SYSTEMS LTD | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 1982/03/19 | N / N | DISCONTINUED | openFDA ↗ |
| A087567-001 | HYDROCORTISONE SODIUM SUCCINATE | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 250MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A087568-001 | HYDROCORTISONE SODIUM SUCCINATE | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A087569-001 | HYDROCORTISONE SODIUM SUCCINATE | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A088667-001 | HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 1984/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A088668-001 | HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 250MG BASE/VIAL | 1984/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A088669-001 | HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL | 1984/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A088670-001 | HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL | 1984/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A088712-001 | HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 1984/06/08 | N / N | DISCONTINUED | openFDA ↗ |
| A089577-001 | A-HYDROCORT | ABBOTT LABORATORIES HOSP PRODUCTS DIV | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 1989/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A089578-001 | A-HYDROCORT | ABBOTT LABORATORIES HOSP PRODUCTS DIV | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 250MG BASE/VIAL | 1989/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A089579-001 | A-HYDROCORT | ABBOTT LABORATORIES HOSP PRODUCTS DIV | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL | 1989/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A089580-001 | A-HYDROCORT | ABBOTT LABORATORIES HOSP PRODUCTS DIV | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL | 1989/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A214050-001 | HYDROCORTISONE SODIUM SUCCINATE | CIPLA LTD | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 2024/09/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217191-001 | HYDROCORTISONE SODIUM SUCCINATE | ZYDUS PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 2026/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219856-001 | HYDROCORTISONE SODIUM SUCCINATE | APOTEX INC | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | 2026/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N009866-001 | SOLU-CORTEF | PHARMACIA AND UPJOHN CO | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 100MG BASE/VIAL | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N009866-002 | SOLU-CORTEF | PHARMACIA AND UPJOHN CO | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 250MG BASE/VIAL | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N009866-003 | SOLU-CORTEF | PHARMACIA AND UPJOHN CO | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 500MG BASE/VIAL | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N009866-004 | SOLU-CORTEF | PHARMACIA AND UPJOHN CO | INJECTABLE | INJECTION | HYDROCORTISONE SODIUM SUCCINATE: EQ 1GM BASE/VIAL | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | 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 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265863See source | 2026/09/02 | Official source ↗ |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264656See source | 2026/06/10 | Official source ↗ |
| Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized | 国药准字H20264410See source | 2026/05/19 | Official source ↗ |
| Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | 国药准字H20093293See source | 2026/05/11 | Official source ↗ |
| Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263039See source | 2026/01/05 | Official source ↗ |
| Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20084319See source | 2025/04/29 | Official source ↗ |
| Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20084318See source | 2025/04/29 | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20253862See source | 2025/04/15 | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20253863See source | 2025/04/15 | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058653See source | 2024/08/01 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H12020493See source | 2024/03/28 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H12020486See source | 2024/03/28 | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058654See source | 2024/01/22 | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H20266277See source | 2026/10/13 | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H20266276See source | 2026/10/13 | Official source ↗ |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264655See source | 2026/06/10 | Official source ↗ |
NHSA approval numbers 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H12020486See source | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20253862See source | — | Official source ↗ |
| Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | 国药准字H200932930.05g | — | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058654See source | — | Official source ↗ |
| Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20084318See source | — | Official source ↗ |
| Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263039See source | — | Official source ↗ |
| Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized | 国药准字H20264410See source | — | Official source ↗ |
| Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265863See source | — | Official source ↗ |
| Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265756See source | — | Official source ↗ |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264655See source | — | Official source ↗ |
| Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | 国药准字H200932930.05g | — | Official source ↗ |
| Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20084318See source | — | Official source ↗ |
| Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263039See source | — | Official source ↗ |
| Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265863See source | — | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H12020493See source | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20253863See source | — | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058653See source | — | Official source ↗ |
| Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20084319See source | — | Official source ↗ |
| Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265757See source | — | Official source ↗ |
| Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264656See source | — | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058653See source | — | Official source ↗ |
| Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20084319See source | — | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H12020486See source | — | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058654See source | — | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H12020493See source | — | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058653See source | — | Official source ↗ |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20058654See source | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H20266276See source | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H20266276See source | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H20266277See source | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H20266277See source | — | Official source ↗ |
Under review 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2502416 | 2025/07/08 | Official source ↗ |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601653 | 2026/07/10 | Official source ↗ |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601652 | 2026/07/10 | Official source ↗ |
| Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | CYHS2601434 | 2026/06/17 | Official source ↗ |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | CYHS2600644 | 2026/03/11 | Official source ↗ |
| Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | CYHS2600513 | 2026/02/25 | Official source ↗ |
| Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized | CYHS2503584 | 2025/09/30 | Official source ↗ |
| Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized | CYHS2503087 | 2025/08/23 | Official source ↗ |
| Xizang An Xing Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized | CYHS2503086 | 2025/08/23 | Official source ↗ |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | CYHS2502300 | 2025/06/27 | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shenyang Guang Da Pharmaceutical Co., Ltd. romanized | CYHS2502100 | 2025/06/12 | Official source ↗ |
| Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Shenyang Guang Da Pharmaceutical Co., Ltd. romanized | CYHS2502099 | 2025/06/12 | Official source ↗ |
| Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | CYHS2501100 | 2025/03/18 | Official source ↗ |
| Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | CYHS2501099 | 2025/03/18 | Official source ↗ |
| Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | CYHS2402621 | 2024/08/13 | Official source ↗ |
| Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | CYHS2402620 | 2024/08/13 | Official source ↗ |
Generic-filing companies this year 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601653 | 2026/07/10 | Official source ↗ |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2601652 | 2026/07/10 | Official source ↗ |
| Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | CYHS2601434 | 2026/06/17 | Official source ↗ |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | CYHS2600644 | 2026/03/11 | Official source ↗ |
| Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanized | CYHS2600513 | 2026/02/25 | Official source ↗ |
API companies with A status 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized | Y20250000227 | 2026/09/04 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20250000198 | 2026/09/08 | Official source ↗ |
| Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | Y20240001012 | 2026/03/02 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized | Y20220000589 | 2024/09/30 | Official source ↗ |
| Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20190009439 | 2026/07/09 | Official source ↗ |
| Tianjin Bio Chemical Pharmaceutical Co., Ltd. romanized | Y20190007427 | 2024/08/15 | 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-088. 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 ↗ · 30-79 · 2020/09/08
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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