Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202501
Company: AVET LIFESCIENCES

Products on ANDA 202501

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIDOFOVIR	CIDOFOVIR	EQ 375MG BASE/5ML (EQ 75MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202501

CIDOFOVIR

SOLUTION;INTRAVENOUS; EQ 375MG BASE/5ML (EQ 75MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIDOFOVIR	CIDOFOVIR	EQ 375MG BASE/5ML (EQ 75MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	202501	AVET LIFESCIENCES
CIDOFOVIR	CIDOFOVIR	EQ 375MG BASE/5ML (EQ 75MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	201276	MYLAN INSTITUTIONAL