Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090096
Company: CHARTWELL RX
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 Discontinued None No No
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;15MG TABLET;ORAL Discontinued None No No
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25MG;15MG TABLET;ORAL Discontinued None 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
09/25/2008 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-3 Labeling-Package Insert

Label is not available on this site.

12/13/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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