# MONISTAT 3 COMBINATION PACK
> **NDA021261** · New Drug Application · Sponsor: MEDTECH PRODUCTS · Approved 2001-02-02
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021261)
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