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As of Nov 13, 2026, NDA 208313 (Infugem), held by Sun Pharm, was first approved by FDA on Jul 16, 2018, with 2 approved supplements and 2 published complete response letters.
First approved: Jul 16, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 2
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below
Date
Submission
Status
Documents
Jul 16, 2018
Original applicationNew dosage form · 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
