Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040707
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG 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
02/27/2007 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
09/16/2007 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET;ORAL Prescription No AB 202556 ACCORD HLTHCARE
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET;ORAL Prescription No AB 040707 ACTAVIS ELIZABETH
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET;ORAL Prescription No AB 040807 IPCA LABS LTD
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET;ORAL Prescription No AB 040702 LEADING PHARMA LLC

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