Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090416
Company: GLENMARK GENERICS
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
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.

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 GENERICS
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 GENERICS
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076204 TEVA

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