Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020696
Company: PAR PHARM INC

Products on NDA 020696

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANTIZOL	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020696

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020696Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020696Orig1s006ltr.pdf
12/13/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/08/2000	SUPPL-1	Efficacy-New Indication	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20696s001ltr.pdf

Labels for NDA 020696

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020696Orig1s006lbl.pdf