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Application 205699
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BOSENTAN | BOSENTAN | TABLET;ORAL | 62.5MG | No | No |
| 002 | BOSENTAN | BOSENTAN | TABLET;ORAL | 125MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-058 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-058 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-058 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-058 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-059 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-059 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-059 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-059 | Bosentan | Bosentan | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76406 | ORIG | 2023-11-06 |
| 58805 | ORIG | 2019-05-21 |