Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073281
Company: SANDOZ
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
04/30/1992 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
01/19/2012 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

12/16/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-6 Labeling

Label is not available on this site.

01/20/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/12/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/12/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/13/1993 SUPPL-1 Labeling

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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