Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076265
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription AB No No
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription AB No No
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG 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
07/08/2002 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
08/20/2020 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

08/03/2020 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

08/03/2020 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/11/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/11/2013 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/11/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/03/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/03/2010 SUPPL-14 Labeling

Label is not available on this site.

04/09/2007 SUPPL-9 Labeling

Label is not available on this site.

08/08/2006 SUPPL-7 Labeling

Label is not available on this site.

LISINOPRIL AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 077606 AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076265 HIKMA INTL PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 204058 INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 077912 LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076230 PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076262 SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076007 SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076194 WATSON LABS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription Yes AB 019888 ALVOGEN

TABLET;ORAL; 12.5MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 077606 AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076265 HIKMA INTL PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 204058 INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 077912 LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076230 PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076262 SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076007 SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076194 WATSON LABS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription Yes AB 019888 ALVOGEN

TABLET;ORAL; 25MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 077606 AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076265 HIKMA INTL PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 204058 INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 077912 LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076230 PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076262 SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076007 SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076194 WATSON LABS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription Yes AB 019888 ALVOGEN

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