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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076980
Company: TEVA

Products on ANDA 076980

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;7.5MG	TABLET;ORAL	Prescription	AB	No	No
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	25MG;15MG	TABLET;ORAL	Prescription	AB	No	Yes
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;15MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076980

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2007	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-15	Labeling-Package Insert		Label is not available on this site.
12/13/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/13/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/31/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/29/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/29/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076980

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;7.5MG	TABLET;ORAL	Prescription	No	AB	090718	GLENMARK PHARMS
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;7.5MG	TABLET;ORAL	Prescription	No	AB	076980	TEVA

TABLET;ORAL; 25MG;15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	25MG;15MG	TABLET;ORAL	Prescription	No	AB	090718	GLENMARK PHARMS
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	25MG;15MG	TABLET;ORAL	Prescription	No	AB	076980	TEVA

TABLET;ORAL; 12.5MG;15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;15MG	TABLET;ORAL	Prescription	No	AB	090718	GLENMARK PHARMS
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE	12.5MG;15MG	TABLET;ORAL	Prescription	No	AB	076980	TEVA

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