Application 207518
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE
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 |
|---|---|---|---|---|---|
| 43598-678 | AZACITIDINE | AZACITIDINE | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 63323-771 | Azacitidine | Azacitidine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-771 | Azacitidine | Azacitidine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-771 | Azacitidine | Azacitidine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63759-0003 | AZACITIDINE | azacitidine for | Shilpa Medicare Limited | ANDA | Current |
| 64679-096 | AZACITIDINE | azacitidine | Wockhardt USA LLC. | ANDA | Current |
| 64679-096 | AZACITIDINE | azacitidine | Wockhardt USA LLC. | ANDA | Current |
| 64679-096 | AZACITIDINE | azacitidine | Wockhardt USA LLC. | ANDA | Current |
| 69097-805 | azacitidine for | azacitidine | Cipla USA Inc. | ANDA | Current |
| 69097-805 | azacitidine for | azacitidine | Cipla USA Inc. | ANDA | Current |
| 69097-805 | azacitidine for | azacitidine | Cipla USA Inc. | ANDA | Current |
| 72485-201 | AZACITIDINE | azacitidine | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-201 | AZACITIDINE | azacitidine | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72606-558 | AZACITIDINE | azacitidine | CELLTRION USA, INC. | ANDA | Current |