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Sign in to subscribeBetamethasone Sodium Phosphate Injection
Matched- Active ingredients (original)
- BETAMETHASONE SODIUM PHOSPHATE
- 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 applications1
RLD applicantSCHERING CORP SUB SCHERING PLOUGH CORP
Currently marketed products: 0 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A085738-001 | BETAMETHASONE SODIUM PHOSPHATE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | BETAMETHASONE SODIUM PHOSPHATE: EQ 3MG BASE/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N017561-001 | CELESTONE | SCHERING CORP SUB SCHERING PLOUGH CORP | INJECTABLE | INJECTION | BETAMETHASONE SODIUM PHOSPHATE: EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |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 25
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Henan Li Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20265964See source | 2026/09/15 | Official source ↗ |
| Anhui Mei Lai Pharma Co., Ltd. romanized | 国药准字H20265447See source | 2026/08/04 | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20264484See source | 2026/05/19 | Official source ↗ |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263689See source | 2026/03/25 | Official source ↗ |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | 国药准字H20263606See source | 2026/03/17 | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20263541See source | 2026/03/10 | Official source ↗ |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized | 国药准字H20263158See source | 2026/01/20 | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263004See source | 2026/01/05 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256197See source | 2025/12/09 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256196See source | 2025/12/09 | Official source ↗ |
| Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized | 国药准字H20255643See source | 2025/09/30 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255052See source | 2025/07/29 | Official source ↗ |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | 国药准字H20255017See source | 2025/07/29 | Official source ↗ |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | 国药准字H20255016See source | 2025/07/29 | Official source ↗ |
| Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized | 国药准字H20254262See source | 2025/05/27 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363See source | 2025/05/27 | Official source ↗ |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20254024See source | 2025/04/30 | Official source ↗ |
| Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20253583See source | 2025/03/11 | Official source ↗ |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20253417See source | 2025/02/20 | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20247307See source | 2024/12/05 | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307See source | 2024/12/05 | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20249438See source | 2024/11/22 | Official source ↗ |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20244496See source | 2024/07/30 | Official source ↗ |
| Beijing Bu Lin Bio Technology Co., Ltd. romanized | 国药准字H20244487See source | 2024/07/30 | Official source ↗ |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244470See source | 2024/07/22 | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20243882See source | 2024/06/04 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917See source | 2023/08/29 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917See source | 2023/08/29 | Official source ↗ |
| Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20265913See source | 2026/09/08 | Official source ↗ |
NHSA approval numbers 27
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H20249438See source | — | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20243882See source | — | Official source ↗ |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | 国药准字H20255016See source | — | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307See source | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20264484See source | — | Official source ↗ |
| Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20253583See source | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917See source | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256197See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065249See source | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263004See source | — | Official source ↗ |
| Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized | 国药准字H20263606See source | — | Official source ↗ |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20244496See source | — | Official source ↗ |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244470See source | — | Official source ↗ |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20253417See source | — | Official source ↗ |
| Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized | 国药准字H20254262See source | — | Official source ↗ |
| Beijing Liu Huan Pharma Co., Ltd. romanized | 国药准字H20244487See source | — | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20247307See source | — | Official source ↗ |
| Anhui Mei Lai Pharma Co., Ltd. romanized | 国药准字H20265447See source | — | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255052See source | — | Official source ↗ |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20254024See source | — | Official source ↗ |
| Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263689See source | — | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20243882See source | — | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307See source | — | Official source ↗ |
| Yu Song Yuan Pharma Co., Ltd. romanized | 国药准字H20253583See source | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20064917See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065249See source | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20263004See source | — | Official source ↗ |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244470See source | — | Official source ↗ |
| Shaanxi Li Cai Pharma Co., Ltd. romanized | 国药准字H20253417See source | — | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20247307See source | — | Official source ↗ |
| Anhui Mei Lai Pharma Co., Ltd. romanized | 国药准字H20265447See source | — | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255052See source | — | Official source ↗ |
| Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20058307See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20254363See source | — | Official source ↗ |
| Jiangsu Shen Long Pharma Co., Ltd. romanized | 国药准字H20255017See source | — | Official source ↗ |
| Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized | 国药准字H20255643See source | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20237102See source | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20256196See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065250See source | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H20237102See source | — | Official source ↗ |
| Shandong Sheng Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20065250See source | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | CYHS2601687 | 2026/07/15 | Official source ↗ |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2600995 | 2026/04/28 | Official source ↗ |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | CYHS2600316 | 2026/01/30 | Official source ↗ |
| Anhui Jun Da Gao Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | CYHS2502807 | 2025/08/04 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | CYHB2601954 | 2026/10/23 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | CYHS2601687 | 2026/07/15 | Official source ↗ |
| Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2600995 | 2026/04/28 | Official source ↗ |
| Henan Run Hong Pharmaceutical Co., Ltd. romanized | CYHS2600316 | 2026/01/30 | Official source ↗ |
API companies with A status 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240001492 | 2026/11/04 | Official source ↗ |
| Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20230000084 | 2025/10/27 | Official source ↗ |
| CURIA SPAIN S.A.U. | Y20230001012 | 2026/07/13 | Official source ↗ |
| Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | Y20190009520 | 2025/02/20 | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20190007551 | 2025/11/10 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20190006978 | 2025/08/09 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized | Y20170002316 | 2026/01/24 | 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 ↗ · 32-17 · 2021/10/21
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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