Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083177
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription AB No No
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/12/1973 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-221 Labeling-Package Insert

Label is not available on this site.

01/07/2005 SUPPL-205 Labeling

Label is not available on this site.

07/07/2004 SUPPL-200 Labeling

Label is not available on this site.

07/29/2002 SUPPL-197 Manufacturing (CMC)-Facility

Label is not available on this site.

11/15/2002 SUPPL-196 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/2001 SUPPL-195 Manufacturing (CMC)-Facility

Label is not available on this site.

08/22/2002 SUPPL-193 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/2000 SUPPL-192 Labeling

Label is not available on this site.

01/28/2000 SUPPL-191 Manufacturing (CMC)-Facility

Label is not available on this site.

02/03/2000 SUPPL-190 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/30/1999 SUPPL-188 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-187 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-186 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-185 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-184 Manufacturing (CMC)

Label is not available on this site.

01/13/1998 SUPPL-183 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-182 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-181 Manufacturing (CMC)

Label is not available on this site.

08/17/1995 SUPPL-180 Labeling

Label is not available on this site.

06/03/1993 SUPPL-179 Labeling

Label is not available on this site.

03/12/1993 SUPPL-178 Labeling

Label is not available on this site.

10/06/1995 SUPPL-177 Manufacturing (CMC)

Label is not available on this site.

09/09/1992 SUPPL-176 Manufacturing (CMC)

Label is not available on this site.

09/09/1992 SUPPL-175 Manufacturing (CMC)

Label is not available on this site.

11/10/1988 SUPPL-174 Bioequivalence

Label is not available on this site.

03/31/1988 SUPPL-170 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-169 Manufacturing (CMC)

Label is not available on this site.

06/29/1987 SUPPL-168 Manufacturing (CMC)

Label is not available on this site.

01/14/1987 SUPPL-166 Manufacturing (CMC)

Label is not available on this site.

01/14/1987 SUPPL-165 Manufacturing (CMC)

Label is not available on this site.

02/20/1987 SUPPL-164 Manufacturing (CMC)

Label is not available on this site.

03/30/1982 SUPPL-158 Manufacturing (CMC)

Label is not available on this site.

03/30/1982 SUPPL-157 Manufacturing (CMC)

Label is not available on this site.

03/30/1982 SUPPL-156 Manufacturing (CMC)

Label is not available on this site.

HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 202556 ACCORD HLTHCARE
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 040780 AUROBINDO PHARMA
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 085182 HERITAGE PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 040807 IPCA LABS LTD
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 083177 IVAX SUB TEVA PHARMS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 040702 LEADING PHARMA LLC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 040735 MYLAN PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 087059 OXFORD PHARMS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 040412 PRINSTON INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 203018 SCIEGEN PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Prescription No AB 040907 UNICHEM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 202556 ACCORD HLTHCARE
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 040780 AUROBINDO PHARMA
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 085182 HERITAGE PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 084878 HIKMA INTL PHARMS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 040807 IPCA LABS LTD
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 083177 IVAX SUB TEVA PHARMS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 040702 LEADING PHARMA LLC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 040735 MYLAN PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 087068 OXFORD PHARMS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 040412 PRINSTON INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 203018 SCIEGEN PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription No AB 040907 UNICHEM

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