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As of Nov 13, 2026, NDA 216984 (Tepylute), held by Shorla, was first approved by FDA on Jun 25, 2024, with 3 approved supplements and 0 published complete response letters.
First approved: Jun 25, 2024
Review: Standard
Supplements approved: 3
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 4 submissions below
Date
Submission
Status
Documents
Jun 25, 2024
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
