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FDA NDA · NDA012541

DEPO-PROVERA

Sponsor: PFIZER

APPLICATION
NDA012541
TYPE
NDA
ORIGINAL APPROVAL
1960-09-23
LATEST ACTION
2017-04-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DEPO-PROVERA · ReferenceDiscontinued
MEDROXYPROGESTERONE ACETATE 400MG/ML · INJECTABLE · INJECTION
DEPO-PROVERA · ReferenceDiscontinued
MEDROXYPROGESTERONE ACETATE 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2017-04-03Labeling · Supplement 86 · standard — Label ↗AP
2017-03-15Labeling · Supplement 88 · standard — Label ↗AP
2016-12-16Labeling · Supplement 85 · standard — Label ↗AP
2016-06-10Labeling · Supplement 84 · standard — Label ↗AP
2015-06-11Labeling · Supplement 83 · standard — Letter ↗AP
2014-06-09Manufacturing (CMC) · Supplement 82 · standardAP
2012-11-20Manufacturing (CMC) · Supplement 78 · standardAP
2000-04-03Manufacturing (CMC) · Supplement 69 · standardAP
1997-11-28Labeling · Supplement 67 · standardAP
1995-11-28Manufacturing (CMC) · Supplement 66 · standardAP
1995-09-07Labeling · Supplement 57AP
1995-04-18Manufacturing (CMC) · Supplement 65 · standardAP
1995-04-12Manufacturing (CMC) · Supplement 64 · standardAP
1994-07-27Manufacturing (CMC) · Supplement 63 · standardAP
1994-06-16Manufacturing (CMC) · Supplement 62 · standardAP
1994-02-18Labeling · Supplement 60 · standardAP
1994-02-17Manufacturing (CMC) · Supplement 61 · standardAP
1993-06-23Manufacturing (CMC) · Supplement 58 · standardAP
1990-02-20Labeling · Supplement 56AP
1980-05-20Manufacturing (CMC) · Supplement 49 · standardAP
1979-07-13Labeling · Supplement 48AP
1979-01-19Manufacturing (CMC) · Supplement 37 · standardAP
1978-12-04Labeling · Supplement 42AP
1976-11-01Labeling · Supplement 38AP
1976-11-01Manufacturing (CMC) · Supplement 39 · standardAP
1976-11-01Manufacturing (CMC) · Supplement 41 · standardAP
1976-01-16Labeling · Supplement 36AP
1960-09-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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