Composition
- Active ingredients
- ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) · SolutionANDA219099-001 · Prescription
- ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SolutionNDA208574-001 · Discontinued
- ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SolutionThis page
- ROMIDEPSIN 10MG/VIAL · PowderANDA206254-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA208574.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Romidepsin
- Route
- Intravenous
- Dosage form
- Solution
- Applicant
- Teva Pharms USA Inc
- Status
- Discontinued
- FDA approval
- 13 Mar 2020
- Application
- NDA208574-002