Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019717
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter None No No
HUMULIN 70/30 PEN INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 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
04/25/1989 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-169 Supplement

Label is not available on this site.

11/15/2019 SUPPL-168 Supplement

Label is not available on this site.

08/22/2019 SUPPL-165 Supplement

Label is not available on this site.

11/06/2018 SUPPL-161 Supplement

Label is not available on this site.

01/06/2017 SUPPL-146 Supplement

Label is not available on this site.

03/12/2015 SUPPL-135 Supplement

Label is not available on this site.

02/25/2015 SUPPL-133 Supplement

Label is not available on this site.

09/12/2014 SUPPL-129 Supplement

Label is not available on this site.

06/04/2014 SUPPL-126 Supplement

Label is not available on this site.

01/15/2014 SUPPL-124 Supplement

Label is not available on this site.

12/09/2013 SUPPL-123 Supplement

Label is not available on this site.

04/11/2014 SUPPL-122 Supplement

Label is not available on this site.

04/03/2014 SUPPL-121 Supplement

Label is not available on this site.

01/24/2014 SUPPL-120 Supplement

Label is not available on this site.

03/18/2014 SUPPL-119 Supplement

Label is not available on this site.

03/04/2014 SUPPL-118 Supplement

Label is not available on this site.

12/12/2013 SUPPL-116 Supplement

Label is not available on this site.

08/15/2013 SUPPL-115 Supplement

Label is not available on this site.

05/31/2013 SUPPL-113 Supplement

Label is not available on this site.

05/30/2013 SUPPL-112 Supplement

Label is not available on this site.

08/21/2013 SUPPL-111 Supplement

Label is not available on this site.

05/10/2013 SUPPL-108 Supplement

Label is not available on this site.

02/15/2013 SUPPL-107 Supplement

Label is not available on this site.

06/12/2013 SUPPL-105 Supplement

Label is not available on this site.

11/07/2013 SUPPL-101 Supplement

Label is not available on this site.

03/09/2013 SUPPL-99 Supplement

Label is not available on this site.

11/07/2013 SUPPL-98 Supplement

Label is not available on this site.

06/10/2010 SUPPL-94 Supplement

Label is not available on this site.

03/21/2012 SUPPL-93 Supplement

Label is not available on this site.

03/16/2009 SUPPL-87 Supplement

Label is not available on this site.

08/22/2007 SUPPL-69 Supplement

Label is not available on this site.

09/07/2007 SUPPL-68 Supplement

Label is not available on this site.

11/09/2005 SUPPL-65 Supplement

Label is not available on this site.

11/10/2004 SUPPL-60 Supplement

Label is not available on this site.

04/23/2004 SUPPL-58 Supplement

Label is not available on this site.

11/19/2003 SUPPL-54 Supplement

Label is not available on this site.

06/22/2003 SUPPL-52 Supplement

Label is not available on this site.

11/17/2003 SUPPL-50 Supplement

Label is not available on this site.

09/25/2002 SUPPL-48 Supplement

Label is not available on this site.

08/29/2002 SUPPL-47 Supplement

Label is not available on this site.

08/29/2002 SUPPL-46 Supplement

Label is not available on this site.

08/29/2002 SUPPL-45 Supplement

Label is not available on this site.

08/21/2002 SUPPL-44 Supplement

Label is not available on this site.

08/21/2002 SUPPL-43 Supplement

Label is not available on this site.

10/25/2002 SUPPL-42 Supplement

Label is not available on this site.

10/03/2002 SUPPL-41 Supplement

Label is not available on this site.

03/29/2002 SUPPL-40 Supplement

Label is not available on this site.

03/22/2002 SUPPL-39 Supplement

Label is not available on this site.

03/14/2002 SUPPL-38 Supplement

Label is not available on this site.

02/28/2002 SUPPL-37 Supplement

Label is not available on this site.

04/02/2002 SUPPL-36 Supplement

Label is not available on this site.

02/05/2002 SUPPL-35 Supplement

Label is not available on this site.

02/12/2003 SUPPL-32 Supplement

Label is not available on this site.

11/01/2002 SUPPL-30 Supplement

Label is not available on this site.

02/25/1999 SUPPL-29 Supplement

Label is not available on this site.

08/06/1998 SUPPL-26 Supplement

Label is not available on this site.

07/16/1997 SUPPL-25 Supplement

Label is not available on this site.

02/20/1998 SUPPL-24 Supplement

Label is not available on this site.

04/18/1997 SUPPL-23 Supplement

Label is not available on this site.

01/28/1997 SUPPL-22 Supplement

Label is not available on this site.

07/10/1996 SUPPL-20 Supplement

Label is not available on this site.

07/26/1996 SUPPL-19 Supplement

Label is not available on this site.

05/22/1996 SUPPL-18 Supplement

Label is not available on this site.

05/31/1996 SUPPL-17 Supplement

Label is not available on this site.

01/26/1996 SUPPL-16 Supplement

Label is not available on this site.

02/15/1996 SUPPL-15 Supplement

Label is not available on this site.

11/09/1995 SUPPL-14 Supplement

Label is not available on this site.

09/29/1995 SUPPL-13 Supplement

Label is not available on this site.

03/09/1995 SUPPL-12 Supplement

Label is not available on this site.

02/22/1995 SUPPL-11 Supplement

Label is not available on this site.

02/10/1995 SUPPL-10 Supplement

Label is not available on this site.

12/07/1992 SUPPL-9 Supplement

Label is not available on this site.

02/23/1994 SUPPL-8 Supplement

Label is not available on this site.

01/27/1992 SUPPL-7 Supplement

Label is not available on this site.

01/11/1994 SUPPL-6 Supplement

Label is not available on this site.

03/12/1991 SUPPL-5 Supplement

Label is not available on this site.

09/24/1990 SUPPL-4 Supplement

Label is not available on this site.

04/22/1990 SUPPL-3 Supplement

Label is not available on this site.

05/23/1990 SUPPL-2 Supplement

Label is not available on this site.

05/26/1989 SUPPL-1 Supplement

Label is not available on this site.

HUMULIN 70/30

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

INJECTABLE;INJECTION; 30 UNITS/ML;70 UNITS/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HUMULIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019717 LILLY
HUMULIN 70/30 PEN INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019717 LILLY
NOVOLIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019991 NOVO NORDISK INC

HUMULIN 70/30 PEN

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

INJECTABLE;INJECTION; 30 UNITS/ML;70 UNITS/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HUMULIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019717 LILLY
HUMULIN 70/30 PEN INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019717 LILLY
NOVOLIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019991 NOVO NORDISK INC

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