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As of Nov 13, 2026, NDA 14691 (Alkeran), held by Apotex, was first approved by FDA on Jan 17, 1964, with 20 approved supplements and 0 published complete response letters.
First approved: Jan 17, 1964
Review: Priority
Supplements approved: 20
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 21 submissions below
Date
Submission
Status
Documents
Jan 17, 1964
Original applicationNew molecular entity · Priority review
Approved
None posted
Products
1 strengths and forms
Product
Active ingredient
Marketing
Alkeran2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral
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
