Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072011
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG 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
06/17/1988 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-32 Labeling-Package Insert

Label is not available on this site.

03/25/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/24/1999 SUPPL-13 Labeling

Label is not available on this site.

06/24/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-9 Labeling

Label is not available on this site.

10/21/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/13/1993 SUPPL-6 Labeling

Label is not available on this site.

05/15/1992 SUPPL-5 Labeling

Label is not available on this site.

04/29/1992 SUPPL-4 Labeling

Label is not available on this site.

02/05/1992 SUPPL-3 Labeling

Label is not available on this site.

03/28/1991 SUPPL-2 Labeling

Label is not available on this site.

05/01/1989 SUPPL-1 Labeling

Label is not available on this site.

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 50MG;75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAXZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription Yes AB 019129 MYLAN PHARMS INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 073467 ANI PHARMS INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 071251 APOTEX INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 072011 SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 071851 WATSON LABS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET;ORAL Prescription No AB 208360 ZYDUS PHARMS

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