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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204058
Company: INVAGEN PHARMS

Products on ANDA 204058

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	Yes
LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/07/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204058

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

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