← FDA DRUG APPROVALS

FDA NDA · NDA018713

MYCELEX

Sponsor: BAYER HLTHCARE

APPLICATION
NDA018713
TYPE
NDA
ORIGINAL APPROVAL
1983-06-17
LATEST ACTION
2002-12-15
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Discontinued

Products

MYCELEX · ReferenceDiscontinued
CLOTRIMAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TROCHE/LOZENGE · ORAL

Approval history

2002-12-15Labeling · Supplement 19 · standard — Label ↗AP
2001-03-26Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
2001-01-23Manufacturing (CMC) · Supplement 16 · standardAP
1999-10-07Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
1999-06-30Manufacturing (CMC) · Supplement 13 · standardAP
1992-09-29Efficacy · Supplement 7AP
1991-12-30Labeling · Supplement 11AP
1990-01-18Manufacturing (CMC) · Supplement 10 · standardAP
1989-09-15Manufacturing (CMC) · Supplement 9 · standardAP
1988-12-07Manufacturing (CMC) · Supplement 8 · standardAP
1988-01-27Manufacturing (CMC) · Supplement 5 · standardAP
1988-01-15Manufacturing (CMC) · Supplement 6 · standardAP
1987-06-03Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1985-09-11Labeling · Supplement 2AP
1984-11-13Manufacturing (CMC) · Supplement 1 · standardAP
1983-06-17Type 3 - New Dosage Form · Original · standardAP
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 →