Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076113
Company: MYLAN
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
07/01/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76113tadF.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/26/2014 SUPPL-26 Labeling-Container/Carton Labels

Label is not available on this site.

09/06/2013 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

09/06/2013 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/25/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

02/25/2010 SUPPL-19 Labeling-Container/Carton Labels

Label is not available on this site.

12/04/2007 SUPPL-10 Labeling

Label is not available on this site.

09/23/2004 SUPPL-4 Labeling

Label is not available on this site.

06/06/2003 SUPPL-2 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 076674 APOTEX INC
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 075776 IVAX SUB TEVA 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 076113 MYLAN
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 MALTA

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 076674 APOTEX INC
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 075776 IVAX SUB TEVA 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 076113 MYLAN
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 MALTA

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 076674 APOTEX INC
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 075776 IVAX SUB TEVA 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 076113 MYLAN
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 MALTA

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