← FDA DRUG APPROVALS

FDA NDA · NDA021583

DEPO-SUBQ PROVERA

medroxyprogesterone acetate

Sponsor: PFIZER

APPLICATION
NDA021583
TYPE
NDA
ORIGINAL APPROVAL
2004-12-17
LATEST ACTION
2025-12-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEPO-SUBQ PROVERA 104 · ReferencePrescription
MEDROXYPROGESTERONE ACETATE 104MG/0.65ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-12-12Labeling · Supplement 45 · standard — Letter ↗AP
2024-12-16Labeling · Supplement 43 · standard — Label ↗AP
2024-07-11Labeling · Supplement 40 · standard — Letter ↗AP
2020-12-04Efficacy · Supplement 34 · standard — Letter ↗AP
2020-12-04Efficacy · Supplement 33 · standard — Letter ↗AP
2019-12-23Labeling · Supplement 24 · standard — Letter ↗AP
2019-12-23Labeling · Supplement 16 · unknown — Letter ↗AP
2019-12-23Labeling · Supplement 29 · standard — Letter ↗AP
2018-03-01Labeling · Supplement 17 · unknown — Letter ↗AP
2017-01-31Labeling · Supplement 23 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 31 · standard — Label ↗AP
2016-10-14Labeling · Supplement 32 · standard — Letter ↗AP
2016-08-04Manufacturing (CMC) · Supplement 27 · standardAP
2016-02-29Manufacturing (CMC) · Supplement 13 · standardAP
2015-01-30Labeling · Supplement 25 · standard — Letter ↗AP
2015-01-23Labeling · Supplement 26 · standard — Letter ↗AP
2009-07-15Manufacturing (CMC) · Supplement 11 — Label ↗AP
2007-10-05Labeling · Supplement 6 · standard — Letter ↗AP
2005-11-08Labeling · Supplement 3 · standard — Letter ↗AP
2005-05-02Labeling · Supplement 1 · standard — Letter ↗AP
2004-12-17Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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