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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076063
Company: HIKMA INTL PHARMS

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 40MG TABLET;ORAL Discontinued None No No
LISINOPRIL LISINOPRIL 30MG 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

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2024 SUPPL-67 Labeling-Package Insert

Label is not available on this site.
05/13/2020 SUPPL-65 Labeling-Package Insert

Label is not available on this site.
09/15/2016 SUPPL-64 Labeling-Package Insert

Label is not available on this site.
09/15/2016 SUPPL-63 Labeling-Package Insert

Label is not available on this site.
09/15/2016 SUPPL-61 Labeling-Package Insert

Label is not available on this site.
09/15/2016 SUPPL-60 Labeling-Package Insert

Label is not available on this site.
06/04/2015 SUPPL-57 Labeling-Package Insert

Label is not available on this site.
06/04/2015 SUPPL-56 Labeling-Package Insert

Label is not available on this site.
06/04/2015 SUPPL-55 Labeling-Container/Carton Labels

Label is not available on this site.
06/04/2015 SUPPL-54 Labeling-Package Insert

Label is not available on this site.
06/04/2015 SUPPL-53 Labeling-Package Insert

Label is not available on this site.
06/04/2015 SUPPL-51 Labeling-Package Insert

Label is not available on this site.
08/14/2013 SUPPL-49 Labeling-Package Insert

Label is not available on this site.
06/04/2015 SUPPL-48 Labeling-Container/Carton Labels

Label is not available on this site.
02/28/2013 SUPPL-47 Labeling-Package Insert

Label is not available on this site.
02/28/2013 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
02/28/2013 SUPPL-42 Labeling-Package Insert

Label is not available on this site.
08/05/2013 SUPPL-40 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
02/17/2010 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
09/10/2009 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
01/28/2008 SUPPL-33 Labeling

Label is not available on this site.
08/21/2009 SUPPL-31 Labeling

Label is not available on this site.
06/25/2007 SUPPL-29 Labeling

Label is not available on this site.
02/16/2007 SUPPL-19 Labeling

Label is not available on this site.
03/13/2006 SUPPL-13 Labeling

Label is not available on this site.
03/13/2006 SUPPL-11 Labeling

Label is not available on this site.
06/27/2003 SUPPL-3 Labeling

Label is not available on this site.
06/27/2003 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.
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