Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090718
Company: GLENMARK PHARMS
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 12.5MG;15MG TABLET;ORAL Prescription AB No No
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25MG;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
03/17/2010 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
08/20/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/13/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/13/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/29/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

07/26/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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; 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

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

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