APPLICATION
ANDA040159
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-09
LATEST ACTION
2024-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MEDROXYPROGESTERONE ACETATEPrescription
MEDROXYPROGESTERONE ACETATE 10MG · TABLET · ORAL
MEDROXYPROGESTERONE ACETATEPrescription
MEDROXYPROGESTERONE ACETATE 2.5MG · TABLET · ORAL
MEDROXYPROGESTERONE ACETATEPrescription
MEDROXYPROGESTERONE ACETATE 5MG · TABLET · ORAL
Approval history
2024-09-16Labeling · Supplement 34 · standardAP
2021-06-07Labeling · Supplement 29 · standardAP
2007-12-26Labeling · Supplement 23AP
2002-04-10Manufacturing (CMC) · Supplement 21AP
2001-12-14Manufacturing (CMC) · Supplement 19AP
2001-10-26Labeling · Supplement 20AP
2000-05-16Manufacturing (CMC) · Supplement 18AP
2000-01-24Manufacturing (CMC) · Supplement 15AP
1999-12-21Manufacturing (CMC) · Supplement 16AP
1999-09-24Labeling · Supplement 17AP
1999-07-07Labeling · Supplement 14AP
1999-05-20Manufacturing (CMC) · Supplement 13AP
1999-03-26Manufacturing (CMC) · Supplement 11AP
1999-03-26Labeling · Supplement 12AP
1999-03-11Manufacturing (CMC) · Supplement 7AP
1999-02-05Manufacturing (CMC) · Supplement 9AP
1998-12-01Manufacturing (CMC) · Supplement 8AP
1998-09-25Manufacturing (CMC) · Supplement 6AP
1998-09-25Manufacturing (CMC) · Supplement 5AP
1996-12-27Manufacturing (CMC) · Supplement 1AP
1996-08-09OriginalAP
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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