# FOMEPIZOLE
> **ANDA078368** · Abbreviated New Drug Application (Generic) · Sponsor: AM REGENT · Approved 2007-12-14
## Drug
- **FDA Application Number:** ANDA078368
- **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:** AM REGENT
- **Manufacturer:** American Regent, Inc.
- **First approval:** 2007-12-14
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078368)
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