Details for New Drug Application (NDA): 208574
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NDA 208574 describes ROMIDEPSIN, which is a drug marketed by Fresenius Kabi Usa and Teva Pharms Usa Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the ROMIDEPSIN profile page.
The generic ingredient in ROMIDEPSIN is romidepsin. There are three drug master file entries 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 are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
Summary for 208574
| Tradename: | ROMIDEPSIN |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | romidepsin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208574
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROMIDEPSIN | romidepsin | SOLUTION;INTRAVENOUS | 208574 | NDA | Teva Parenteral Medicines, Inc. | 0703-4004 | 0703-4004-01 | 1 VIAL in 1 CARTON (0703-4004-01) / 5.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 13, 2020 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 13, 2020 | TE: | RLD: | Yes | |||||
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