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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076961
Company: SANDOZ

Products on ANDA 076961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	AB	No	No
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2005	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
08/20/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
01/03/2014	SUPPL-15	Labeling-Patient Package Insert		Label is not available on this site.
01/03/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/31/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076961

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 10MG;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	No	AB	079245	AUROBINDO PHARMA
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	No	AB	090228	INVAGEN PHARMS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	No	AB	076961	SANDOZ

TABLET;ORAL; 20MG;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	No	AB	079245	AUROBINDO PHARMA
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	No	AB	090228	INVAGEN PHARMS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	No	AB	076961	SANDOZ

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