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FDA NDA · NDA020696

ANTIZOL

Sponsor: PAR PHARM INC

APPLICATION
NDA020696
TYPE
NDA
ORIGINAL APPROVAL
1997-12-04
LATEST ACTION
2020-12-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ANTIZOL · ReferenceDiscontinued
FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-12-23Labeling · Supplement 6 · standard — Label ↗AP
2013-12-13Manufacturing (CMC) · Supplement 5 · standardAP
2000-12-08Efficacy · Supplement 1 · standard — Letter ↗AP
1997-12-04Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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