Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075999
Company: SANDOZ
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/2001/75999ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/08/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/20/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/25/2003 SUPPL-4 Labeling

Label is not available on this site.

01/17/2003 SUPPL-1 Labeling

Label is not available on this site.

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