← FDA DRUG APPROVALS

FDA ANDA · ANDA076721

MEGESTROL ACETATE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA076721
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-01
LATEST ACTION
2007-06-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

MEGESTROL ACETATEPrescription
MEGESTROL ACETATE 40MG/ML · SUSPENSION · ORAL

Approval history

2007-06-28Labeling · Supplement 2AP
2004-11-01OriginalAP
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 →