Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 018781
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN N INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter 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
10/28/1982 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-188 Supplement

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11/15/2019 SUPPL-187 Supplement

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08/22/2019 SUPPL-184 Supplement

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11/06/2018 SUPPL-181 Supplement

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01/06/2017 SUPPL-167 Supplement

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04/05/2016 SUPPL-163 Supplement

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04/22/2016 SUPPL-161 Supplement

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02/19/2016 SUPPL-160 Supplement

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10/20/2015 SUPPL-159 Supplement

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10/08/2015 SUPPL-158 Supplement

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07/15/2015 SUPPL-157 Supplement

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03/12/2015 SUPPL-156 Supplement

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03/03/2015 SUPPL-155 Supplement

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02/25/2015 SUPPL-154 Supplement

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01/12/2015 SUPPL-153 Supplement

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09/12/2014 SUPPL-150 Supplement

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06/04/2014 SUPPL-147 Supplement

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06/10/2014 SUPPL-146 Supplement

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01/15/2014 SUPPL-145 Supplement

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12/09/2013 SUPPL-144 Supplement

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04/11/2014 SUPPL-143 Supplement

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04/03/2014 SUPPL-142 Supplement

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01/24/2014 SUPPL-141 Supplement

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03/18/2014 SUPPL-140 Supplement

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03/04/2014 SUPPL-139 Supplement

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12/12/2013 SUPPL-137 Supplement

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08/15/2013 SUPPL-136 Supplement

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05/31/2013 SUPPL-134 Supplement

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05/30/2013 SUPPL-133 Supplement

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08/21/2013 SUPPL-132 Supplement

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02/21/2013 SUPPL-131 Supplement

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03/25/2013 SUPPL-130 Supplement

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05/10/2013 SUPPL-129 Supplement

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02/15/2013 SUPPL-128 Supplement

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06/12/2013 SUPPL-126 Supplement

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12/03/2012 SUPPL-125 Supplement

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11/07/2013 SUPPL-122 Supplement

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03/09/2013 SUPPL-121 Supplement

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09/30/2014 SUPPL-120 Supplement

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11/07/2013 SUPPL-118 Supplement

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06/10/2010 SUPPL-114 Supplement

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03/21/2012 SUPPL-113 Supplement

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03/16/2009 SUPPL-108 Supplement

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08/22/2007 SUPPL-89 Supplement

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09/07/2007 SUPPL-88 Supplement

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11/09/2005 SUPPL-85 Supplement

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02/25/2005 SUPPL-80 Supplement

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09/03/2004 SUPPL-79 Supplement

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04/21/2004 SUPPL-76 Supplement

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11/19/2003 SUPPL-74 Supplement

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06/22/2003 SUPPL-72 Supplement

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11/20/2003 SUPPL-70 Supplement

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08/29/2002 SUPPL-67 Supplement

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08/29/2002 SUPPL-66 Supplement

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08/29/2002 SUPPL-65 Supplement

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08/21/2002 SUPPL-64 Supplement

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08/21/2002 SUPPL-63 Supplement

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10/31/2002 SUPPL-62 Supplement

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04/02/2002 SUPPL-61 Supplement

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11/20/2003 SUPPL-60 Supplement

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02/12/2003 SUPPL-57 Supplement

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07/07/2000 SUPPL-56 Supplement

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10/29/1999 SUPPL-55 Supplement

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11/05/2002 SUPPL-54 Supplement

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02/25/1999 SUPPL-53 Supplement

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08/06/1998 SUPPL-50 Supplement

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06/24/1997 SUPPL-49 Supplement

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02/20/1998 SUPPL-48 Supplement

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04/16/1997 SUPPL-47 Supplement

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01/28/1997 SUPPL-46 Supplement

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07/10/1996 SUPPL-44 Supplement

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07/26/1996 SUPPL-43 Supplement

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05/22/1996 SUPPL-42 Supplement

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05/31/1996 SUPPL-41 Supplement

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01/26/1996 SUPPL-40 Supplement

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02/15/1996 SUPPL-39 Supplement

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11/09/1995 SUPPL-38 Supplement

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09/29/1995 SUPPL-37 Supplement

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03/09/1995 SUPPL-36 Supplement

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02/22/1995 SUPPL-35 Supplement

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02/10/1995 SUPPL-34 Supplement

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10/27/1995 SUPPL-33 Supplement

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12/07/1992 SUPPL-32 Supplement

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01/11/1994 SUPPL-31 Supplement

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03/12/1991 SUPPL-30 Supplement

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09/24/1990 SUPPL-29 Supplement

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08/17/1990 SUPPL-28 Supplement

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04/03/1991 SUPPL-27 Supplement

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01/23/1989 SUPPL-26 Supplement

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07/29/1988 SUPPL-25 Supplement

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03/03/1988 SUPPL-24 Supplement

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03/24/1988 SUPPL-23 Supplement

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10/27/1987 SUPPL-22 Supplement

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10/27/1987 SUPPL-21 Supplement

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10/27/1987 SUPPL-20 Supplement

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07/10/1987 SUPPL-19 Supplement

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07/13/1987 SUPPL-18 Supplement

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07/13/1987 SUPPL-17 Supplement

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07/28/1987 SUPPL-16 Supplement

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10/27/1987 SUPPL-15 Supplement

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07/31/1987 SUPPL-14 Supplement

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06/28/1988 SUPPL-13 Supplement

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12/26/1984 SUPPL-10 Supplement

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02/14/1985 SUPPL-9 Supplement

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02/29/1984 SUPPL-8 Supplement

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07/25/1984 SUPPL-7 Supplement

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10/12/1983 SUPPL-6 Supplement

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08/24/1983 SUPPL-5 Supplement

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01/27/1983 SUPPL-4 Supplement

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01/31/1983 SUPPL-3 Supplement

Label is not available on this site.

12/02/1982 SUPPL-2 Supplement

Label is not available on this site.

12/02/1982 SUPPL-1 Supplement

Label is not available on this site.

HUMULIN N

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

INJECTABLE;INJECTION; 100 UNITS/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HUMULIN N INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018781 LILLY
NOVOLIN N INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019959 NOVO NORDISK INC

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