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): 077912
Company: LUPIN

Withdrawal Notice

Healthcare Professional Sheet

Products on ANDA 077912

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 077912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2006	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
03/17/2023	SUPPL-43	Labeling-Patient Package Insert		Label is not available on this site.
03/17/2023	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
03/17/2023	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
03/17/2023	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
02/28/2014	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
02/28/2014	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/28/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/31/2009	SUPPL-8	Labeling		Label is not available on this site.
01/11/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077912

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	076262	AIPING PHARM INC
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	076674	COREPHARMA
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	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	076262	AIPING PHARM INC
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	076674	COREPHARMA
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	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	076262	AIPING PHARM INC
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	076674	COREPHARMA
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	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

Top