← FDA DRUG APPROVALS

FDA NDA · NDA018592

MONISTAT 5

Sponsor: PERSONAL PRODS

APPLICATION
NDA018592
TYPE
NDA
ORIGINAL APPROVAL
1989-10-27
LATEST ACTION
1989-10-27
ROUTE
VAGINAL
DOSAGE FORM
TAMPON
MARKETING STATUS
Discontinued

Products

MONISTAT 5Discontinued
MICONAZOLE NITRATE 100MG · TAMPON · VAGINAL

Approval history

1989-10-27Type 3 - New Dosage Form · Original · standardAP
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 →