Application 210931
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUSULFAN | BUSULFAN | INJECTABLE;INJECTION | 6MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-160 | Busulfan | Busulfan | Fresenius Kabi USA, LLC | ANDA | Current |
| 72485-210 | Busulfan | Busulfan | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72606-559 | Busulfan | Busulfan | CELLTRION USA, INC. | ANDA | Current |