Application 207475
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZACITIDINE | AZACITIDINE | POWDER;INTRAVENOUS, SUBCUTANEOUS | 100MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-578 | Azacitidine | Azacitidine | NorthStar RxLLC | ANDA | Current |
| 16714-578 | Azacitidine | Azacitidine | NorthStar RxLLC | ANDA | Current |
| 16729-306 | Azacitidine | Azacitidine | Accord Healthcare Inc. | ANDA | Current |
| 16729-306 | Azacitidine | Azacitidine | Accord Healthcare Inc. | ANDA | Current |
| 16729-306 | Azacitidine | Azacitidine | Accord Healthcare Inc. | ANDA | Current |
| 16729-306 | Azacitidine | Azacitidine | Accord Healthcare Inc. | ANDA | Current |
| 68001-527 | Azacitidine | Azacitidine | BluePoint Laboratories | ANDA | Current |