# GYNAZOLE-1
> **ANDA200923** · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS ISRAEL · Approved 2012-05-18
## Drug
- **FDA Application Number:** ANDA200923
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GYNAZOLE-1
- **Generic name:** BUTOCONAZOLE NITRATE
- **Active ingredients:** BUTOCONAZOLE NITRATE
- **Dosage form:** CREAM
- **Route:** VAGINAL
- **Marketing status:** Prescription
- **Sponsor:** PADAGIS ISRAEL
- **Manufacturer:** Padagis Israel Pharmaceuticals Ltd
- **First approval:** 2012-05-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200923)
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