← FDA DRUG APPROVALS

FDA NDA · NDA019828

OXICONAZOLE NITRATE

Sponsor: FOUGERA PHARMS

APPLICATION
NDA019828
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2004-01-23
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

OXISTAT · ReferencePrescription
OXICONAZOLE NITRATE EQ 1% BASE · CREAM · TOPICAL

Approval history

2004-01-23Labeling · Supplement 9 · standard — Letter ↗AP
1997-08-18Efficacy · Supplement 7 · standardAP
1997-08-18Efficacy · Supplement 3AP
1997-08-08Manufacturing (CMC) · Supplement 8 · standardAP
1994-06-07Manufacturing (CMC) · Supplement 6 · standardAP
1992-09-30Efficacy · Supplement 5 · standardAP
1989-11-28Manufacturing (CMC) · Supplement 2 · standardAP
1989-07-07Labeling · Supplement 1AP
1988-12-30Type 1 - New Molecular Entity · 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 →