Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075944
Company: SUN PHARM INDS LTD
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75944ta2.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

11/25/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

08/05/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

08/05/2013 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

08/05/2013 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

08/05/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

03/12/2010 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

03/08/2010 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

02/22/2010 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

09/24/2007 SUPPL-12 Labeling

Label is not available on this site.

02/11/2003 SUPPL-2 Labeling

Label is not available on this site.

02/11/2003 SUPPL-1 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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