Orange Book product · Brand (NDA)

ANTIZOL

FOMEPIZOLE

Brand (NDA)NDA 020696DISCN PAR PHARM INC

Dec 04, 1997

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 04, 1997
28 yr 11 mo ago
Today
Patent 7553863 expires
Listed drug substance patent expiration.
Jun 30, 2027
in 1 yr 1 mo

Active ingredient

FOMEPIZOLE

Strength

1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 020696

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7553863	Jun 30, 2027	in 1 yr 1 mo	SubstanceProduct