← FDA Drug Approvals (Drugs@FDA)

MONISTAT 3 COMBINATION PACK

NDA · New Drug Application · Sponsor: MEDTECH PRODUCTS · Approved 2001-02-02

Drug application

FDA Application #
NDA021261
Application type
New Drug Application
Brand name
MONISTAT 3 COMBINATION PACK
Generic name
MICONAZOLE NITRATE
Active ingredients
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL, VAGINAL
Marketing status
Over-the-counter
Sponsor
MEDTECH PRODUCTS
Manufacturer
Insight Pharmaceuticals LLC
First approval
2001-02-02

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown