APPLICATION
NDA011839
TYPE
NDA
ORIGINAL APPROVAL
1959-06-18
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROVERA · ReferencePrescription
MEDROXYPROGESTERONE ACETATE 5MG · TABLET · ORAL
PROVERA · ReferencePrescription
MEDROXYPROGESTERONE ACETATE 2.5MG · TABLET · ORAL
PROVERA · ReferencePrescription
MEDROXYPROGESTERONE ACETATE 10MG · TABLET · ORAL
Approval history
2016-12-01Manufacturing (CMC) · Supplement 77 · standardAP
1998-03-31Labeling · Supplement 67 · standardAP
1995-11-28Manufacturing (CMC) · Supplement 66 · standardAP
1993-06-23Manufacturing (CMC) · Supplement 63 · standardAP
1993-06-23Manufacturing (CMC) · Supplement 61 · standardAP
1993-04-30Labeling · Supplement 62 · standardAP
1992-06-19Manufacturing (CMC) · Supplement 59 · standardAP
1991-12-18Labeling · Supplement 58AP
1991-11-19Labeling · Supplement 60AP
1989-10-06Manufacturing (CMC) · Supplement 53 · standardAP
1988-06-03Manufacturing (CMC) · Supplement 52 · standardAP
1987-10-26Labeling · Supplement 50AP
1985-11-01Manufacturing (CMC) · Supplement 46 · standardAP
1979-07-23Efficacy · Supplement 39AP
1979-06-06Efficacy · Supplement 35AP
1975-10-21REMS · Supplement 29 · standardAP
1973-10-04Manufacturing (CMC) · Supplement 25 · standardAP
1959-06-18Type 1 - New Molecular Entity · Original · standardAP
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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