Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078368
Company: AM REGENT

Products on ANDA 078368

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOMEPIZOLE	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078368s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2020	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078368

FOMEPIZOLE

INJECTABLE;INJECTION; 1.5GM/1.5ML (1GM/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOMEPIZOLE	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078368	AM REGENT
FOMEPIZOLE	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE;INJECTION	Prescription	No	AP	216791	GLAND PHARMA LTD
FOMEPIZOLE	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078639	MYLAN INSTITUTIONAL
FOMEPIZOLE	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078537	NAVINTA LLC