Application 206254
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROMIDEPSIN | ROMIDEPSIN | POWDER;INTRAVENOUS | 10MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-926 | Romidepsin | Romidepsin | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-926 | Romidepsin | Romidepsin | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69685 | ORIG | 2021-12-20 |