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As of Nov 14, 2026, NDA 208042 (Cassipa), held by Teva Pharms USA, was first approved by FDA on Sep 7, 2018, with 9 approved supplements and 1 published complete response letter.
First approved: Sep 7, 2018
Review: Standard
Supplements approved: 9
Complete response letters: 1
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 10 submissions below
Date
Submission
Status
Documents
Sep 7, 2018
Original applicationNew formulation or manufacturer · Standard review
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
