Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077321
Company: LUPIN
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 30MG TABLET;ORAL Prescription AB No No
LISINOPRIL LISINOPRIL 40MG 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
09/09/2005 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
02/18/2016 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

04/09/2015 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

04/09/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/09/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

04/09/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/04/2011 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/29/2009 SUPPL-15 Labeling

Label is not available on this site.

11/18/2009 SUPPL-12 Labeling

Label is not available on this site.

08/08/2006 SUPPL-4 Labeling

Label is not available on this site.

01/30/2007 SUPPL-2 Labeling

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; 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

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

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