Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
As of Nov 14, 2026, NDA 18613 (Ovide), held by Taro, was first approved by FDA on Aug 2, 1982, with 8 approved supplements and 0 published complete response letters.
First approved: Aug 2, 1982
Review: Standard
Supplements approved: 8
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 9 submissions below
Date
Submission
Status
Documents
Aug 2, 1982
Original applicationNew molecular entity · Standard review
Approved
None posted
Products
1 strengths and forms
Product
Active ingredient
Marketing
Ovide0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical
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
