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As of Nov 14, 2026, NDA 21167 (Vivelle), held by Novartis, was first approved by FDA on Aug 16, 2000, with 0 approved supplements and 0 published complete response letters.
First approved: Aug 16, 2000
Review: Standard
Supplements approved: 0
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first
Date
Submission
Status
Documents
Aug 16, 2000
Original applicationNew indication · 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
