Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021018
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMALOG MIX 50/50 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 50 UNITS/ML;50 UNITS/ML INJECTABLE;INJECTION Prescription None No No
HUMALOG MIX 50/50 KWIKPEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 50 UNITS/ML;50 UNITS/ML INJECTABLE;INJECTION Prescription None No No
HUMALOG MIX 50/50 PEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 50 UNITS/ML;50 UNITS/ML INJECTABLE;INJECTION 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
12/22/1999 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-129 Supplement

Label is not available on this site.

11/15/2019 SUPPL-127 Supplement

Label is not available on this site.

01/06/2017 SUPPL-111 Supplement

Label is not available on this site.

02/25/2015 SUPPL-100 Supplement

Label is not available on this site.

09/12/2014 SUPPL-96 Supplement

Label is not available on this site.

06/04/2014 SUPPL-95 Supplement

Label is not available on this site.

04/11/2014 SUPPL-93 Supplement

Label is not available on this site.

04/03/2014 SUPPL-92 Supplement

Label is not available on this site.

01/24/2014 SUPPL-91 Supplement

Label is not available on this site.

03/18/2014 SUPPL-90 Supplement

Label is not available on this site.

08/15/2013 SUPPL-88 Supplement

Label is not available on this site.

03/28/2013 SUPPL-85 Supplement

Label is not available on this site.

02/15/2013 SUPPL-81 Supplement

Label is not available on this site.

01/30/2013 SUPPL-77 Supplement

Label is not available on this site.

09/26/2018 SUPPL-74 Supplement

Label is not available on this site.

09/26/2018 SUPPL-70 Supplement

Label is not available on this site.

10/30/2011 SUPPL-69 Supplement

Label is not available on this site.

03/11/2013 SUPPL-67 Supplement

Label is not available on this site.

03/21/2012 SUPPL-56 Supplement

Label is not available on this site.

03/16/2009 SUPPL-49 Supplement

Label is not available on this site.

08/22/2007 SUPPL-41 Supplement

Label is not available on this site.

05/01/2008 SUPPL-35 Supplement

Label is not available on this site.

09/06/2007 SUPPL-34 Supplement

Label is not available on this site.

09/07/2007 SUPPL-23 Supplement

Label is not available on this site.

11/19/2003 SUPPL-11 Supplement

Label is not available on this site.

10/25/2002 SUPPL-4 Supplement

Label is not available on this site.

04/05/2002 SUPPL-3 Supplement

Label is not available on this site.

03/21/2002 SUPPL-2 Supplement

Label is not available on this site.

02/08/2002 SUPPL-1 Supplement

Label is not available on this site.

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