APPLICATION
ANDA089386
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-09
LATEST ACTION
1997-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCRINDiscontinued
MEDROXYPROGESTERONE ACETATE 10MG · TABLET · ORAL
Approval history
1997-11-28Manufacturing (CMC) · Supplement 14AP
1995-10-23Manufacturing (CMC) · Supplement 13AP
1993-03-04Manufacturing (CMC) · Supplement 10AP
1992-06-19Labeling · Supplement 9AP
1990-12-13Labeling · Supplement 7AP
1990-02-21Manufacturing (CMC) · Supplement 4AP
1990-02-21Manufacturing (CMC) · Supplement 2AP
1990-02-21Manufacturing (CMC) · Supplement 5AP
1990-02-21Manufacturing (CMC) · Supplement 3AP
1989-12-06Labeling · Supplement 6AP
1989-08-30Labeling · Supplement 1AP
1989-08-21Bioequivalence · Supplement 8AP
1987-09-09OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.