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As of Nov 13, 2026, NDA 208574 (Romidepsin), held by Teva Pharms USA Inc, was first approved by FDA on Mar 13, 2020, with 1 approved supplement and 3 published complete response letters.
First approved: Mar 13, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 3
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below
Mar 13, 2020
Original applicationNew formulation or manufacturer · Standard review
Romidepsin10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous
Romidepsin27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
