Application 208354
- Type
- ANDA
- Sponsor
- SIGMAPHARM LABS LLC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42291-018 | AMBRISENTAN | AMBRISENTAN | AvKARE | ANDA | Current |
| 42291-019 | AMBRISENTAN | AMBRISENTAN | AvKARE | ANDA | Current |
| 42794-051 | AMBRISENTAN | AMBRISENTAN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-051 | AMBRISENTAN | AMBRISENTAN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-052 | AMBRISENTAN | AMBRISENTAN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-052 | AMBRISENTAN | AMBRISENTAN | Sigmapharm Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76415 | ORIG | 2023-11-06 |