Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201276
Company: MYLAN INSTITUTIONAL

Products on ANDA 201276

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201276Orig1s000Approv.pdf

Therapeutic Equivalents for ANDA 201276

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