Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076063
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 30MG 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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2016 SUPPL-64 Labeling-Package Insert

Label is not available on this site.

09/15/2016 SUPPL-63 Labeling-Package Insert

Label is not available on this site.

09/15/2016 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

09/15/2016 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

06/04/2015 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

06/04/2015 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

06/04/2015 SUPPL-55 Labeling-Container/Carton Labels

Label is not available on this site.

06/04/2015 SUPPL-54 Labeling-Package Insert

Label is not available on this site.

06/04/2015 SUPPL-53 Labeling-Package Insert

Label is not available on this site.

06/04/2015 SUPPL-51 Labeling-Package Insert

Label is not available on this site.

08/14/2013 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

06/04/2015 SUPPL-48 Labeling-Container/Carton Labels

Label is not available on this site.

02/28/2013 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

08/05/2013 SUPPL-40 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/17/2010 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

09/10/2009 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

01/28/2008 SUPPL-33 Labeling

Label is not available on this site.

08/21/2009 SUPPL-31 Labeling

Label is not available on this site.

06/25/2007 SUPPL-29 Labeling

Label is not available on this site.

02/16/2007 SUPPL-19 Labeling

Label is not available on this site.

03/13/2006 SUPPL-13 Labeling

Label is not available on this site.

03/13/2006 SUPPL-11 Labeling

Label is not available on this site.

06/27/2003 SUPPL-3 Labeling

Label is not available on this site.

06/27/2003 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.

LISINOPRIL

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076102 APOTEX INC
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076063 HIKMA INTL PHARMS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075752 IVAX SUB TEVA PHARMS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076071 MYLAN
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076180 PRINSTON INC
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075994 SANDOZ
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription No AB 078402 WOCKHARDT
ZESTRIL LISINOPRIL 2.5MG TABLET;ORAL Prescription Yes AB 019777 ALVOGEN MALTA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076102 APOTEX INC
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076063 HIKMA INTL PHARMS
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075752 IVAX SUB TEVA PHARMS
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076071 MYLAN
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076180 PRINSTON INC
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075994 SANDOZ
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 078402 WOCKHARDT
PRINIVIL LISINOPRIL 5MG TABLET;ORAL Prescription No AB 019558 MERCK
ZESTRIL LISINOPRIL 5MG TABLET;ORAL Prescription Yes AB 019777 ALVOGEN MALTA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076102 APOTEX INC
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076063 HIKMA INTL PHARMS
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075752 IVAX SUB TEVA PHARMS
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076071 MYLAN
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076180 PRINSTON INC
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075994 SANDOZ
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 078402 WOCKHARDT
PRINIVIL LISINOPRIL 10MG TABLET;ORAL Prescription No AB 019558 MERCK
ZESTRIL LISINOPRIL 10MG TABLET;ORAL Prescription Yes AB 019777 ALVOGEN MALTA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076102 APOTEX INC
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076063 HIKMA INTL PHARMS
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075752 IVAX SUB TEVA PHARMS
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076071 MYLAN
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075994 SANDOZ
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 078402 WOCKHARDT
PRINIVIL LISINOPRIL 20MG TABLET;ORAL Prescription No AB 019558 MERCK
ZESTRIL LISINOPRIL 20MG TABLET;ORAL Prescription Yes AB 019777 ALVOGEN MALTA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076102 APOTEX INC
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076063 HIKMA INTL PHARMS
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075752 IVAX SUB TEVA PHARMS
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076071 MYLAN
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075994 SANDOZ
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 078402 WOCKHARDT
PRINIVIL LISINOPRIL 40MG TABLET;ORAL Prescription No AB 019558 MERCK
ZESTRIL LISINOPRIL 40MG TABLET;ORAL Prescription Yes AB 019777 ALVOGEN MALTA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 202554 ACCORD HLTHCARE
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076102 APOTEX INC
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 077622 AUROBINDO
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076063 HIKMA INTL PHARMS
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 203508 INVAGEN PHARMS
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075752 IVAX SUB TEVA PHARMS
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 077321 LUPIN
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076071 MYLAN
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075743 PRINSTON INC
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076164 PRINSTON INC
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075994 SANDOZ
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 075944 SUN PHARM INDS LTD
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 076059 WATSON LABS
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Prescription No AB 078402 WOCKHARDT
ZESTRIL LISINOPRIL 30MG TABLET;ORAL Prescription Yes AB 019777 ALVOGEN MALTA

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