Application 209324
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-038 | Bosentan | Bosentan | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-038 | Bosentan | Bosentan | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-039 | Bosentan | Bosentan | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-039 | Bosentan | Bosentan | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76404 | ORIG | 2023-11-06 |