Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071251
Company: APOTEX INC
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
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
12/08/1987 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-41 Labeling-Package Insert

Label is not available on this site.

04/29/2009 SUPPL-40 Labeling

Label is not available on this site.

03/13/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2000 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/05/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/05/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/05/1998 SUPPL-20 Manufacturing (CMC)-New Strength

Label is not available on this site.

05/05/1998 SUPPL-19 Labeling

Label is not available on this site.

06/23/1997 SUPPL-18 Labeling

Label is not available on this site.

04/07/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/23/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/09/1993 SUPPL-12 Labeling

Label is not available on this site.

10/05/1992 SUPPL-11 Labeling

Label is not available on this site.

04/03/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/26/1989 SUPPL-6 Bioequivalence

Label is not available on this site.

10/20/1989 SUPPL-5 Bioequivalence

Label is not available on this site.

12/03/1991 SUPPL-4 Labeling

Label is not available on this site.

05/06/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/02/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/06/1988 SUPPL-1 Manufacturing (CMC)

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

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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