Treats anorexia, cachexia, or an unexplained, significant weight loss. ANDA 76721, held by Pharmobedient. Megestrol Acetate.
As of Nov 15, 2026, ANDA 76721 (Megestrol Acetate), held by Pharmobedient, was first approved by FDA on Nov 1, 2004, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Megestrol Acetate Oral Suspension, USP 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 |
|---|---|---|---|
| Nov 1, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Megestrol Acetate40MG/ML · suspension;oral | Megestrol Acetate | Rx |
| Jun 28, 2007 | Supplement 2Labeling | Approved | None posted |
| Nov 1, 2004 | 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
