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Matched- Active ingredients (original)
- SULINDAC
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
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 applications10
RLD applicantMERCK RESEARCH LABORATORIES DIV MERCK CO INC
Currently marketed products: 6 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A071795-001 | SULINDAC | WATSON LABORATORIES INC | TABLET | ORAL | SULINDAC: 200MG | 1990/04/03 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071891-001 | SULINDAC | WATSON LABORATORIES INC | TABLET | ORAL | SULINDAC: 150MG | 1990/04/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072050-001 | SULINDAC | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | SULINDAC: 150MG | 1991/04/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072051-001 | SULINDAC | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | SULINDAC: 200MG | 1991/04/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072711-001 | SULINDAC | EPIC PHARMA LLC | TABLET | ORAL | SULINDAC: 200MG | 1991/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072711-002 | SULINDAC | EPIC PHARMA LLC | TABLET | ORAL | SULINDAC: 150MG | 1991/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072712-001 | SULINDAC | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | SULINDAC: 150MG | 1991/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A072713-001 | SULINDAC | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | SULINDAC: 200MG | 1991/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A072973-001 | SULINDAC | ANI PHARMACEUTICALS INC | TABLET | ORAL | SULINDAC: 200MG | 1992/02/28 | N / N | DISCONTINUED | openFDA ↗ |
| A072973-002 | SULINDAC | ANI PHARMACEUTICALS INC | TABLET | ORAL | SULINDAC: 150MG | 1992/02/28 | N / N | DISCONTINUED | openFDA ↗ |
| A073039-001 | SULINDAC | RISING PHARMA HOLDINGS INC | TABLET | ORAL | SULINDAC: 200MG | 1993/06/22 | N / N | DISCONTINUED | openFDA ↗ |
| A073039-002 | SULINDAC | RISING PHARMA HOLDINGS INC | TABLET | ORAL | SULINDAC: 150MG | 1993/06/22 | N / N | DISCONTINUED | openFDA ↗ |
| A073262-001 | SULINDAC | EPIC PHARMA LLC | TABLET | ORAL | SULINDAC: 200MG | 1991/09/06 | N / N | DISCONTINUED | openFDA ↗ |
| A073262-002 | SULINDAC | EPIC PHARMA LLC | TABLET | ORAL | SULINDAC: 150MG | 1991/09/06 | N / N | DISCONTINUED | openFDA ↗ |
| N017911-001 | CLINORIL | MERCK RESEARCH LABORATORIES DIV MERCK CO INC | TABLET | ORAL | SULINDAC: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N017911-002 | CLINORIL | MERCK RESEARCH LABORATORIES DIV MERCK CO INC | TABLET | ORAL | SULINDAC: 200MG **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 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Hao Ge Pharma Co., Ltd. romanized | 国药准字H202637460.2g | 2026/03/31 | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202637940.1g | 2026/03/31 | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202637930.2g | 2026/03/31 | Official source ↗ |
| Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized | 国药准字H202634180.2g | 2026/02/10 | Official source ↗ |
| Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized | 国药准字H202634190.15g | 2026/02/10 | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H202633150.2g | 2026/02/02 | Official source ↗ |
NHSA approval numbers 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202637930.2g | — | Official source ↗ |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 国药准字H200335350.1g | — | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H109400910.1g | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H330216270.1g | — | Official source ↗ |
| Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized | 国药准字H202634190.15g | — | Official source ↗ |
| Zhejiang Hao Ge Pharma Co., Ltd. romanized | 国药准字H202637460.2g | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H202633150.2g | — | Official source ↗ |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 国药准字H200335350.1g | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H330216270.1g | — | Official source ↗ |
| Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized | 国药准字H202634190.15g | — | Official source ↗ |
| Zhejiang Hao Ge Pharma Co., Ltd. romanized | 国药准字H202637460.2g | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H202633150.2g | — | Official source ↗ |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 国药准字H200335350.1g | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H330216270.1g | — | Official source ↗ |
| Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized | 国药准字H202634190.15g | — | Official source ↗ |
| Mu Yuan (Anhui) Pharma Co., Ltd. romanized | 国药准字H202633150.2g | — | Official source ↗ |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 国药准字H200335350.1g | — | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H202637940.1g | — | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H109400910.1g | — | Official source ↗ |
| Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized | 国药准字H202634180.2g | — | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H109400910.1g | — | Official source ↗ |
| Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized | 国药准字H202634180.2g | — | Official source ↗ |
| Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized | 国药准字H202634180.2g | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2602279 | 2026/09/15 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2602278 | 2026/09/15 | Official source ↗ |
| Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2503125 | 2025/08/26 | Official source ↗ |
| Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2600077 | 2026/01/08 | Official source ↗ |
| Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2600076 | 2026/01/08 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2602279 | 2026/09/15 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2602278 | 2026/09/15 | Official source ↗ |
| Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2600077 | 2026/01/08 | Official source ↗ |
| Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2600076 | 2026/01/08 | Official source ↗ |
API companies with A status 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hangzhou Fu Si Te Pharma Co., Ltd. romanized | Y20240001431 | 2026/08/13 | Official source ↗ |
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | Y20230001372 | 2026/07/09 | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | Y20190002461 | 2025/01/03 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | Y20190001705 | 2025/02/20 | 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.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 33-29 · 2020/12/21
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