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Drugs@FDA: FDA-Approved Drugs

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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 Discontinued None 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 Discontinued None No No
PRINIVIL LISINOPRIL 2.5MG TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/09/2021 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019558s063lbl.pdf
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
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