Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084878
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Prescription AB No No
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Discontinued None 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
01/31/1977 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
08/17/2011 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

07/12/2006 SUPPL-40 Manufacturing (CMC)-New Strength

Label is not available on this site.

07/12/2006 SUPPL-39 Manufacturing (CMC)-New Strength

Label is not available on this site.

03/24/2004 SUPPL-36 Labeling

Label is not available on this site.

07/28/1992 SUPPL-35 Labeling

Label is not available on this site.

02/07/1991 SUPPL-32 Bioequivalence

Label is not available on this site.

03/28/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/27/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/25/1989 SUPPL-25 Labeling

Label is not available on this site.

11/29/1988 SUPPL-24 Labeling

Label is not available on this site.

12/20/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/20/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/09/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

HYDROCHLOROTHIAZIDE

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

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