Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074026
Company: PLIVA
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
04/26/1996 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
05/29/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

05/17/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

08/08/1997 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

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