Treats anorexia, cachexia, or an unexplained, significant weight loss. ANDA 75671, held by Strides Pharma Intl. Megestrol Acetate.
As of Nov 15, 2026, ANDA 75671 (Megestrol Acetate), held by Strides Pharma Intl, was first approved by FDA on Jul 25, 2001, with 6 approved supplements 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 |
|---|---|---|---|
| Jul 25, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Megestrol Acetate40MG/ML · suspension;oral | Megestrol Acetate | Rx |
| May 19, 2020 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jan 16, 2013 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 4, 2004 | Supplement 11Labeling | Approved | None posted |
| Feb 23, 2004 | Supplement 8Labeling | Approved | None posted |
| Aug 14, 2003 | Supplement 7Labeling | Approved | None posted |
| Oct 1, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Jul 25, 2001 | Original application | Approved |
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
