Active ingredient
Megestrol
24 finished FDA listings contain Megestrol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MEGESTROL ACETATE
- Dosage forms
- Suspension, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 17
- Strengths listed
- 125 mg/ml · 20 mg/1 · 40 mg/1 · 40 mg/ml · 400 mg/10ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6703
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 072423 | STRIDES PHARMA INTL | 1988-08-08 | 3 |
| ANDA 072422 | STRIDES PHARMA INTL | 1988-08-08 | 2 |
| ANDA 074621 | BARR | 1995-11-30 | 3 |
| ANDA 075671 | STRIDES PHARMA INTL | 2001-07-25 | 9 |
| ANDA 076721 | PHARMOBEDIENT | 2004-11-01 | 1 |
| ANDA 077404 | NOVITIUM PHARMA | 2006-02-16 | 4 |
| ANDA 203139 | TWI PHARMS | 2014-08-27 | 2 |
Official labeling on DailyMed
- MEGESTROL ACETATE SUSPENSION [ATLANTIC BIOLOGICALS CORP.] · version 4 · 2026-07-13
- MEGESTROL ACETATE SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-06-17
- MEGESTROL ACETATE SUSPENSION [UPSHER-SMITH LABORATORIES, LLC] · version 19 · 2026-05-01
- MEGESTROL ACETATE SUSPENSION [NATCO PHARMA USA LLC] · version 2 · 2026-01-19
- MEGESTROL ACETATE SUSPENSION [MAJOR PHARMACEUTICALS] · version 2 · 2026-01-16
- MEGESTROL ACETATE SUSPENSION [AMERICAN HEALTH PACKAGING] · version 2 · 2026-01-06
- MEGESTROL ACETATE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 3 · 2025-11-21
- MEGESTROL ACETATE SUSPENSION [XTTRIUM LABORATORIES, INC.] · version 2 · 2025-11-17
- MEGESTROL ACETATE TABLET [MAJOR PHARMACEUTICALS] · version 3 · 2025-09-25
- MEGESTROL ACETATE SUSPENSION [KESIN PHARMA CORPORATION] · version 2 · 2025-09-03
- MEGESTROL ACETATE TABLET [BRYANT RANCH PREPACK] · version 102 · 2025-04-02
- MEGESTROL ACETATE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 3 · 2025-02-26
Showing the 12 most recent of 21 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.