Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075994
Company: SANDOZ
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
07/01/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75994TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/15/2015 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

04/15/2015 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

04/15/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/15/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

08/14/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

02/19/2013 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

02/19/2013 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

02/19/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

02/29/2008 SUPPL-24 Labeling

Label is not available on this site.

08/14/2007 SUPPL-19 Labeling

Label is not available on this site.

08/30/2005 SUPPL-10 Labeling

Label is not available on this site.

06/16/2005 SUPPL-7 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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