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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205670
Company: PRINSTON INC

Products on ANDA 205670

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 205670

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205670

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

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