Application 210715
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMBRISENTAN | AMBRISENTAN | TABLET;ORAL | 5MG | No | No |
| 002 | AMBRISENTAN | AMBRISENTAN | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-386 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-386 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-386 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-386 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-387 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-387 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-387 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 69097-387 | Ambrisentan | Ambrisentan | Cipla USA Inc. | ANDA | Current |
| 76282-684 | Ambrisentan | Ambrisentan | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-685 | Ambrisentan | Ambrisentan | Exelan Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76417 | ORIG | 2023-11-06 |