← FDA DRUG APPROVALS

FDA NDA · NDA020574

GYNE-LOTRIMIN 3

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA020574
TYPE
NDA
ORIGINAL APPROVAL
1998-11-24
LATEST ACTION
2010-04-12
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

GYNE-LOTRIMIN 3 · ReferenceDiscontinued
CLOTRIMAZOLE 2% · CREAM · VAGINAL

Approval history

2010-04-12Labeling · Supplement 6 · standard — Letter ↗AP
2002-01-16Manufacturing (CMC) · Supplement 3 · standardAP
2000-09-01Manufacturing (CMC) · Supplement 2 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 1 · standardAP
1998-11-24Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →