Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073449
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG 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
09/23/1993 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
06/11/2012 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/24/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

11/07/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

12/24/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/15/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-3 Labeling

Label is not available on this site.

08/12/1997 SUPPL-2 Labeling

Label is not available on this site.

08/12/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG;37.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAXZIDE-25 HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription Yes AB 019129 MYLAN PHARMS INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 071251 APOTEX INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 074026 PLIVA
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 073281 SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 073449 WATSON LABS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET;ORAL Prescription No AB 208360 ZYDUS PHARMS

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