Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073467
Company: ANI PHARMS 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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/31/1996 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-5 Manufacturing (CMC)-Facility

Label is not available on this site.

05/17/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

08/08/1997 SUPPL-2 Labeling

Label is not available on this site.

04/13/2000 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

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