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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090416
Company: GLENMARK PHARMS LTD

Products on ANDA 090416

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2010	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
03/02/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/29/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090416

MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	078454	APOTEX INC
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	077536	CHARTWELL RX
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	090416	GLENMARK PHARMS LTD
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	7.5MG	TABLET;ORAL	Prescription	No	AB	076204	TEVA

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	078454	APOTEX INC
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	077536	CHARTWELL RX
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	090416	GLENMARK PHARMS LTD
MOEXIPRIL HYDROCHLORIDE	MOEXIPRIL HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	076204	TEVA

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