FDA Orange Book · active-ingredient family
Medroxyprogesterone acetate
Medroxyprogesterone acetate: 4 brands, 21 generics; first approved Jul 26, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
21
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- PFIZERNDA 0215832004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 104MG/0.65ML INJECTABLE SUBCUTANEOUS Rx - - PFIZERNDA 0202461992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - DEPO-PROVERARLDPFIZERNDA 012541-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued - 400MG/ML INJECTABLE INJECTION Discontinued - - PROVERARLDPFIZERNDA 011839-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Generic (ANDA) products (21)
Abbreviated applications
- MEDROXYPROGESTERONE ACETATEAMNEALANDA 2153972023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATEHIKMAANDA 2143092023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Discontinued - - MEDROXYPROGESTERONE ACETATEEUGIA PHARMAANDA 2128442022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATEEUGIA PHARMAANDA 2128242022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATESUN PHARMANDA 2107602019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Discontinued - - MEDROXYPROGESTERONE ACETATESUN PHARMANDA 2107612019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Discontinued - - MEDROXYPROGESTERONE ACETATECIPLAANDA 2103352019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Discontinued - - MEDROXYPROGESTERONE ACETATEXIROMEDANDA 2102272018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATEAMPHASTAR PHARMS INCANDA 0772352017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATEAMPHASTAR PHARMS INCANDA 0773342017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATESANDOZANDA 0787112009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Discontinued - - MEDROXYPROGESTERONE ACETATETEVA PHARMS USAANDA 0765522004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Discontinued - - MEDROXYPROGESTERONE ACETATEHONG KONGANDA 0765532004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG/ML INJECTABLE INJECTION Rx AB - MEDROXYPROGESTERONE ACETATEDURAMED PHARMS BARRANDA 04031119993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued - 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - MEDROXYPROGESTERONE ACETATEBARRANDA 04015919963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - ESIANDA 0812391992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued - - ESIANDA 0812401992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - ESIANDA 0893861987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - MEDROXYPROGESTERONE ACETATEUPSHER SMITH LABSANDA 0884841984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - AMARIN PHARMSANDA 083242-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - SOLVAYANDA 085686-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG 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
42 yr 10 mo ago
Most recent approval
3 yr 5 mo ago
Approvals span 1984–2023 across 25 FDA applications.
Brand (NDA) 416%
Generic (ANDA) 2184%
Medroxyprogesterone 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.
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