← FDA Drug Approvals (Drugs@FDA)
FOMEPIZOLE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN INSTITUTIONAL · Approved 2008-03-03
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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