Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076071
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LISINOPRIL LISINOPRIL 2.5MG TABLET;ORAL Discontinued None No No
LISINOPRIL LISINOPRIL 5MG TABLET;ORAL Discontinued None No No
LISINOPRIL LISINOPRIL 10MG TABLET;ORAL Discontinued None No No
LISINOPRIL LISINOPRIL 20MG TABLET;ORAL Discontinued None No No
LISINOPRIL LISINOPRIL 30MG TABLET;ORAL Discontinued None No No
LISINOPRIL LISINOPRIL 40MG 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
07/01/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76071ta2.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2016 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

12/26/2015 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

06/13/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

06/13/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/13/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

03/01/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

03/01/2013 SUPPL-21 Labeling-Container/Carton Labels

Label is not available on this site.

03/01/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

03/08/2010 SUPPL-19 Labeling

Label is not available on this site.

10/16/2009 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

02/21/2008 SUPPL-8 Labeling

Label is not available on this site.

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