Treats anorexia, cachexia, or an unexplained, significant weight loss. ANDA 77404, held by Novitium Pharma. Megestrol Acetate.
As of Nov 15, 2026, ANDA 77404 (Megestrol Acetate), held by Novitium Pharma, was first approved by FDA on Feb 16, 2006, with 2 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Megestrol Acetate40MG/ML · suspension;oral | Megestrol Acetate | Rx |
| Feb 29, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 17, 2008 | Supplement 5Labeling | Approved | None posted |
| Feb 16, 2006 | Original application | Approved | None posted |
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
