← FDA DRUG APPROVALS

FDA ANDA · ANDA040311

MEDROXYPROGESTERONE ACETATE

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA040311
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-01
LATEST ACTION
2002-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEDROXYPROGESTERONE ACETATEDiscontinued
MEDROXYPROGESTERONE ACETATE 5MG · TABLET · ORAL
MEDROXYPROGESTERONE ACETATEDiscontinued
MEDROXYPROGESTERONE ACETATE 10MG · TABLET · ORAL
MEDROXYPROGESTERONE ACETATEDiscontinued
MEDROXYPROGESTERONE ACETATE 2.5MG · TABLET · ORAL

Approval history

2002-10-22Manufacturing (CMC) · Supplement 3AP
2002-02-07Manufacturing (CMC) · Supplement 2AP
1999-12-01OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →