Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071851
Company: WATSON LABS
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
11/30/1988 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
06/11/2012 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/24/2002 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

11/07/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

12/24/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/15/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-16 Labeling

Label is not available on this site.

08/12/1997 SUPPL-15 Labeling

Label is not available on this site.

06/08/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/02/1992 SUPPL-13 Labeling

Label is not available on this site.

05/12/1993 SUPPL-9 Bioequivalence

Label is not available on this site.

06/08/1993 SUPPL-5 Labeling

Label is not available on this site.

08/15/1990 SUPPL-4 Labeling

Label is not available on this site.

06/08/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English