Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019558
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRINIVIL LISINOPRIL 5MG TABLET;ORAL Prescription AB No No
PRINIVIL LISINOPRIL 10MG TABLET;ORAL Discontinued None No No
PRINIVIL LISINOPRIL 20MG TABLET;ORAL Discontinued None No No
PRINIVIL LISINOPRIL 40MG TABLET;ORAL Prescription AB No No
PRINIVIL LISINOPRIL 2.5MG TABLET;ORAL Discontinued None 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
12/29/1987 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2018 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019558s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019558Orig1s062ltr.pdf
09/19/2017 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019558s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019558Orig1s061ltr.pdf
10/14/2016 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019558Orig1s060ltr.pdf
08/28/2015 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s059ltr.pdf
08/22/2014 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/08/2015 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s057ltr.pdf
02/26/2013 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019558Orig1s056ltr.pdf
06/07/2012 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf
11/17/2011 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf
06/10/2011 SUPPL-53 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
10/09/2008 SUPPL-52 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf
10/09/2008 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf
02/02/2007 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf
10/18/2006 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf
06/16/2006 SUPPL-47 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf
10/05/2005 SUPPL-46 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019558s046ltr.pdf
03/02/2004 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf
05/29/2003 SUPPL-43 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-558S043_Prinivil.cfm
08/23/2001 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/26/2001 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/05/2004 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr040ltr.pdf
06/09/2000 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/07/2001 SUPPL-38 Labeling

Label is not available on this site.

03/15/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/17/1999 SUPPL-36 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf
09/03/1996 SUPPL-35 Labeling

Label is not available on this site.

11/01/1995 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1995 SUPPL-33 Labeling

Label is not available on this site.

06/26/1995 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1995 SUPPL-31 Labeling

Label is not available on this site.

06/08/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/21/1995 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-28 Labeling

Label is not available on this site.

11/24/1995 SUPPL-27 Efficacy-New Indication

Label is not available on this site.

07/24/1994 SUPPL-26 Labeling

Label is not available on this site.

03/10/1994 SUPPL-25 Labeling

Label is not available on this site.

09/23/1993 SUPPL-24 Labeling

Label is not available on this site.

01/28/1994 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/11/1994 SUPPL-22 Labeling

Label is not available on this site.

01/14/1994 SUPPL-21 Labeling

Label is not available on this site.

03/10/1993 SUPPL-20 Labeling

Label is not available on this site.

09/03/1996 SUPPL-19 Labeling

Label is not available on this site.

09/30/1992 SUPPL-18 Labeling

Label is not available on this site.

05/13/1992 SUPPL-17 Labeling

Label is not available on this site.

05/07/1992 SUPPL-16 Labeling

Label is not available on this site.

01/23/1992 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1992 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1991 SUPPL-11 Labeling

Label is not available on this site.

02/06/1991 SUPPL-10 Labeling

Label is not available on this site.

01/07/1991 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1990 SUPPL-8 Labeling

Label is not available on this site.

06/14/1993 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

08/09/1989 SUPPL-6 Labeling

Label is not available on this site.

01/31/1989 SUPPL-5 Labeling

Label is not available on this site.

03/29/1989 SUPPL-4 Labeling

Label is not available on this site.

08/19/1988 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1988 SUPPL-2 Labeling

Label is not available on this site.

10/25/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/12/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019558s062lbl.pdf
09/19/2017 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019558s061lbl.pdf
10/14/2016 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf
08/28/2015 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf
07/08/2015 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf
02/26/2013 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf
06/07/2012 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf
11/17/2011 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf
05/29/2003 SUPPL-43 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf
12/29/1987 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf

PRINIVIL

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 075994 CASI PHARMS INC
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 077321 LUPIN
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 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

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 075994 CASI PHARMS INC
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 077321 LUPIN
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 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

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