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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076204
Company: TEVA

Products on ANDA 076204

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076204.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/02/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/15/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/31/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076204

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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