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Application 210701
- Type
- ANDA
- Sponsor
- APOTEX
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 |
|---|
| 60505-4552 | Ambrisentan | AMBRISENTAN | Apotex Corp. | ANDA | Current |
| 60505-4552 | Ambrisentan | AMBRISENTAN | Apotex Corp. | ANDA | Current |
| 60505-4553 | Ambrisentan | AMBRISENTAN | Apotex Corp. | ANDA | Current |
| 60505-4553 | Ambrisentan | AMBRISENTAN | Apotex Corp. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76418 | ORIG | 2023-11-06 |