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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076139
Company: TEVA

Products on ANDA 076139

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2003	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/761391Orig1s001,761390Orig1s002ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2009	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/08/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076139

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	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	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	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

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