An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076906
Company: APOTEX INC

Products on ANDA 076906

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	AB	No	No
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	AB	No	No
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076906

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2005	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
12/31/2013	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/08/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/28/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076906

FOSINOPRIL SODIUM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	No	AB	076906	APOTEX INC
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	No	AB	091163	AUROBINDO PHARMA LTD
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	No	AB	076483	CHARTWELL RX
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	No	AB	077222	INVAGEN PHARMS
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	No	AB	205670	PRINSTON INC
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET;ORAL	Prescription	No	AB	076139	TEVA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	No	AB	076906	APOTEX INC
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	No	AB	091163	AUROBINDO PHARMA LTD
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	No	AB	076483	CHARTWELL RX
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	No	AB	077222	INVAGEN PHARMS
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	No	AB	205670	PRINSTON INC
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET;ORAL	Prescription	No	AB	076139	TEVA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	No	AB	076906	APOTEX INC
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	No	AB	091163	AUROBINDO PHARMA LTD
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	No	AB	076483	CHARTWELL RX
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	No	AB	077222	INVAGEN PHARMS
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	No	AB	205670	PRINSTON INC
FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET;ORAL	Prescription	No	AB	076139	TEVA

Top