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FDA NDA · NDA020246

MEDROXYPROGESTERONE ACETATE

Sponsor: PFIZER

APPLICATION
NDA020246
TYPE
NDA
ORIGINAL APPROVAL
1992-10-29
LATEST ACTION
2025-12-12
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEPO-PROVERA · ReferencePrescription
MEDROXYPROGESTERONE ACETATE 150MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-12Labeling · Supplement 74 · standard — Letter ↗AP
2024-07-11Labeling · Supplement 68 · standard — Letter ↗AP
2020-12-04Efficacy · Supplement 62 · standard — Letter ↗AP
2020-12-04Efficacy · Supplement 60 · standard — Letter ↗AP
2020-09-09Labeling · Supplement 57 · standard — Label ↗AP
2020-09-09Labeling · Supplement 43 · unknown — Letter ↗AP
2017-03-16Labeling · Supplement 63 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 58 · standard — Label ↗AP
2016-02-24Manufacturing (CMC) · Supplement 40 · priorityAP
2015-01-30Labeling · Supplement 53 · standard — Label ↗AP
2015-01-23Labeling · Supplement 54 · standard — Letter ↗AP
2014-06-09Manufacturing (CMC) · Supplement 52 · priority — Review ↗AP
2013-09-27Manufacturing (CMC) · Supplement 50 · priority — Review ↗AP
2013-09-10Manufacturing (CMC) · Supplement 49 · priority — Review ↗AP
2013-03-25Manufacturing (CMC) · Supplement 48 · priority — Review ↗AP
2011-07-28Efficacy · Supplement 35 · standard — Label ↗AP
2010-10-15Efficacy · Supplement 36 · standard — Letter ↗AP
2005-10-28Labeling · Supplement 13 · standard — Label ↗AP
2004-11-17Labeling · Supplement 25 · standard — Review ↗AP
2003-05-23Manufacturing (CMC) · Supplement 19 · priority — Label ↗AP
2002-05-23Manufacturing (CMC) · Supplement 18 · priorityAP
2002-04-26Manufacturing (CMC) · Supplement 17 · priorityAP
2001-06-07Manufacturing (CMC) · Supplement 15 · priorityAP
2000-04-03Manufacturing (CMC) · Supplement 14 · priorityAP
1998-08-12Labeling · Supplement 12 · standardAP
1997-01-31Labeling · Supplement 11 · standardAP
1996-03-20Labeling · Supplement 9 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 6 · priorityAP
1995-11-28Manufacturing (CMC) · Supplement 8 · priorityAP
1995-05-03Manufacturing (CMC) · Supplement 7 · priorityAP
1994-12-01Labeling · Supplement 4 · standardAP
1994-12-01Labeling · Supplement 3 · standardAP
1994-02-17Manufacturing (CMC) · Supplement 2 · priorityAP
1992-10-29Type 5 - New Formulation or New Manufacturer · Original · priorityAP
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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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