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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076262
Company: SANDOZ

Products on ANDA 076262

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	AB	No	No
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	AB	No	No
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076262

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2002	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
10/20/2023	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
10/20/2023	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/21/2008	SUPPL-10	Labeling		Label is not available on this site.
06/13/2003	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076262

LISINOPRIL AND HYDROCHLOROTHIAZIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	077606	AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	204058	INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	077912	LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	076230	PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	076262	SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	076007	SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	No	AB	076194	WATSON LABS
ZESTORETIC	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET;ORAL	Prescription	Yes	AB	019888	ALMATICA

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	077606	AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	204058	INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	077912	LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	076230	PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	076262	SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	076007	SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	076194	WATSON LABS
ZESTORETIC	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET;ORAL	Prescription	Yes	AB	019888	ALMATICA

TABLET;ORAL; 25MG;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	077606	AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	204058	INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	077912	LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	076230	PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	076262	SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	076007	SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	No	AB	076194	WATSON LABS
ZESTORETIC	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	Yes	AB	019888	ALMATICA

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