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Application 210342
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|
| 69097-377 | BOSENTAN | bosentan | Cipla USA Inc. | ANDA | Current |
| 69097-377 | BOSENTAN | bosentan | Cipla USA Inc. | ANDA | Current |
| 69097-378 | BOSENTAN | bosentan | Cipla USA Inc. | ANDA | Current |
| 69097-378 | BOSENTAN | bosentan | Cipla USA Inc. | ANDA | Current |