Details for New Drug Application (NDA): 219099
NDA 219099 describes ROMIDEPSIN, which is a drug marketed by Fresenius Kabi Usa, Amneal, and Teva Pharms Usa Inc, and is included in three NDAs. It is available from two suppliers. Additional details are available on the ROMIDEPSIN profile page.
The generic ingredient in ROMIDEPSIN is romidepsin. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
The generic ingredient in ROMIDEPSIN is romidepsin. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
Summary for 219099
| Tradename: | ROMIDEPSIN |
| Applicant: | Amneal |
| Ingredient: | romidepsin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219099
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROMIDEPSIN | romidepsin | SOLUTION;INTRAVENOUS | 219099 | ANDA | Amneal Pharmaceuticals LLC | 70121-2250 | 70121-2250-1 | 1 VIAL in 1 CARTON (70121-2250-1) / 5.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 27.5MG/5.5ML (5MG/ML) | ||||
| Approval Date: | Jun 2, 2026 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Dec 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Complete Access Available with Subscription
