Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087059
Company: OXFORD PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG 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
11/05/1980 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
05/18/2005 SUPPL-17 Labeling

Label is not available on this site.

05/07/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/30/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-12 Labeling

Label is not available on this site.

07/12/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/22/1993 SUPPL-10 Labeling

Label is not available on this site.

08/10/1993 SUPPL-9 Labeling

Label is not available on this site.

07/12/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/26/1992 SUPPL-7 Labeling

Label is not available on this site.

04/20/1990 SUPPL-6 Labeling

Label is not available on this site.

11/15/1989 SUPPL-5 Labeling

Label is not available on this site.

07/27/1983 SUPPL-4 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

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