Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074821
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;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
06/05/1997 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
04/18/2012 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

11/01/2007 SUPPL-23 Labeling

Label is not available on this site.

12/06/2002 SUPPL-17 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/27/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2002 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

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

Label is not available on this site.

07/23/2001 SUPPL-12 Labeling

Label is not available on this site.

11/06/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/12/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/14/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/14/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/20/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription Yes AB 016042 GLAXOSMITHKLINE LLC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 075052 DURAMED PHARMS BARR
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 201407 LANNETT CO INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 074701 MYLAN
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 074821 SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE;ORAL Prescription No AB 208358 ZYDUS PHARMS

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