# FOMEPIZOLE
> **ANDA078639** · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN INSTITUTIONAL · Approved 2008-03-03
## Drug
- **FDA Application Number:** ANDA078639
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** FOMEPIZOLE
- **Generic name:** FOMEPIZOLE
- **Active ingredients:** FOMEPIZOLE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** MYLAN INSTITUTIONAL
- **Manufacturer:** Mylan Institutional LLC
- **First approval:** 2008-03-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078639)
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