FDA Orange Book · active-ingredient family
Megestrol acetate
Megestrol acetate: 3 brands, 15 generics; first approved Oct 02, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
15
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- MEGACE ESRLDENDO OPERATIONSNDA 0217782005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/ML SUSPENSION ORAL Discontinued — - MEGACERLDBRISTOL MYERS SQUIBBNDA 0202641993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Discontinued — - MEGACERLDBRISTOL MYERS SQUIBBNDA 016979—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- MEGESTROL ACETATECHARTWELLANDA 2046882017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/ML SUSPENSION ORAL Discontinued — - MEGESTROL ACETATEHIKMAANDA 2039602017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Discontinued — - MEGESTROL ACETATERSTWI PHARMSANDA 2031392014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/ML SUSPENSION ORAL Rx — - MEGESTROL ACETATENOVITIUM PHARMAANDA 0774042006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Rx AB - MEGESTROL ACETATEPHARMOBEDIENTANDA 0767212004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Rx AB - MEGESTROL ACETATETEVA PHARMSANDA 0756812003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Discontinued — - MEGESTROL ACETATEHIKMAANDA 0759972002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Discontinued — - MEGESTROL ACETATERSSTRIDES PHARMA INTLANDA 0756712001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Rx AB - MEGESTROL ACETATETEVAANDA 0747451998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - MEGESTROL ACETATEBARRANDA 07462119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - MEGESTROL ACETATEHIKMAANDA 07445819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - MEGESTROL ACETATESTRIDES PHARMA INTLANDA 0724221988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - MEGESTROL ACETATERSSTRIDES PHARMA INTLANDA 0724231988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB - MEGESTROL ACETATEUSL PHARMAANDA 0706461987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - MEGESTROL ACETATEUSL PHARMAANDA 0706471987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
39 yr 7 mo ago
Most recent approval
9 yr ago
Approvals span 1987–2017 across 18 FDA applications.
Brand (NDA) 317%
Generic (ANDA) 1583%
Megestrol acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
