← FDA DRUG APPROVALS

FDA ANDA · ANDA075721

LEUPROLIDE ACETATE

Sponsor: GENZYME

APPLICATION
ANDA075721
TYPE
ANDA
ORIGINAL APPROVAL
2001-11-29
LATEST ACTION
2001-11-29
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LEUPROLIDE ACETATEDiscontinued
LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) · SOLUTION · SUBCUTANEOUS

Approval history

2001-11-29OriginalLetterAP
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 →