Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 018780
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter None No No
HUMULIN R INSULIN HUMAN 10000 UNITS/20ML (500 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No No
HUMULIN R KWIKPEN INSULIN HUMAN 1500 UNITS/3ML (500 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No No
HUMULIN R PEN INSULIN 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-176 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s175, s176ltr.pdf
11/15/2019 SUPPL-175 Supplement

Label is not available on this site.

08/22/2019 SUPPL-172 Supplement

Label is not available on this site.

11/06/2018 SUPPL-168 Supplement

Label is not available on this site.

06/24/2016 SUPPL-155 Supplement

Label is not available on this site.

02/26/2016 SUPPL-154 Supplement

Label is not available on this site.

07/08/2016 SUPPL-153 Supplement Label for HUMULIN R U-500

Label is not available on this site.

12/29/2015 SUPPL-152 Supplement Label for HUMULIN R U-500

Label is not available on this site.

10/08/2015 SUPPL-151 Supplement

Label is not available on this site.

02/25/2015 SUPPL-150 Supplement Label for HUMULIN R U- 100

Label is not available on this site.

10/30/2014 SUPPL-149 Supplement

Label is not available on this site.

09/23/2014 SUPPL-148 Supplement Label for HUMULIN R U-500

Label is not available on this site.

06/20/2014 SUPPL-147 Supplement

Label is not available on this site.

03/18/2014 SUPPL-146 Supplement

Label is not available on this site.

08/15/2013 SUPPL-145 Supplement

Label is not available on this site.

05/31/2013 SUPPL-144 Supplement

Label is not available on this site.

05/30/2013 SUPPL-143 Supplement

Label is not available on this site.

05/10/2013 SUPPL-142 Supplement

Label is not available on this site.

11/07/2012 SUPPL-141 Supplement

Label is not available on this site.

01/09/2013 SUPPL-139 Supplement

Label is not available on this site.

12/29/2015 SUPPL-135 Supplement Label for HUMULIN R U-500

Label is not available on this site.

05/25/2018 SUPPL-134 Supplement

Label is not available on this site.

10/30/2011 SUPPL-133 Supplement

Label is not available on this site.

03/09/2013 SUPPL-132 Supplement Label for HUMULIN R U- 100

Label is not available on this site.

06/10/2010 SUPPL-128 Supplement

Label is not available on this site.

03/29/2012 SUPPL-127 Supplement

Label is not available on this site.

05/25/2018 SUPPL-126 Supplement

Label is not available on this site.

03/21/2011 SUPPL-124 Supplement

Label is not available on this site.

03/25/2011 SUPPL-120 Supplement

Label is not available on this site.

09/10/2007 SUPPL-114 Supplement

Label is not available on this site.

08/22/2007 SUPPL-95 Supplement

Label is not available on this site.

09/07/2007 SUPPL-94 Supplement

Label is not available on this site.

02/25/2005 SUPPL-86 Supplement

Label is not available on this site.

11/10/2003 SUPPL-80 Supplement

Label is not available on this site.

02/10/2003 SUPPL-78 Supplement

Label is not available on this site.

10/25/2002 SUPPL-76 Supplement

Label is not available on this site.

08/29/2002 SUPPL-75 Supplement

Label is not available on this site.

08/29/2002 SUPPL-74 Supplement

Label is not available on this site.

08/29/2002 SUPPL-73 Supplement

Label is not available on this site.

08/21/2002 SUPPL-72 Supplement

Label is not available on this site.

08/21/2002 SUPPL-71 Supplement

Label is not available on this site.

10/10/2002 SUPPL-70 Supplement

Label is not available on this site.

03/13/2002 SUPPL-69 Supplement

Label is not available on this site.

02/10/2003 SUPPL-67 Supplement

Label is not available on this site.

04/14/2003 SUPPL-66 Supplement

Label is not available on this site.

08/29/2002 SUPPL-65 Supplement

Label is not available on this site.

04/19/2000 SUPPL-64 Supplement

Label is not available on this site.

11/02/1999 SUPPL-63 Supplement

Label is not available on this site.

02/25/1999 SUPPL-61 Supplement

Label is not available on this site.

08/06/1998 SUPPL-58 Supplement

Label is not available on this site.

02/20/1998 SUPPL-57 Supplement

Label is not available on this site.

04/16/1997 SUPPL-56 Supplement

Label is not available on this site.

04/16/1997 SUPPL-55 Supplement

Label is not available on this site.

01/28/1997 SUPPL-54 Supplement

Label is not available on this site.

07/26/1996 SUPPL-52 Supplement

Label is not available on this site.

07/10/1996 SUPPL-51 Supplement

Label is not available on this site.

07/26/1996 SUPPL-50 Supplement

Label is not available on this site.

04/25/1996 SUPPL-49 Supplement

Label is not available on this site.

02/15/1996 SUPPL-48 Supplement

Label is not available on this site.

02/14/1996 SUPPL-47 Supplement

Label is not available on this site.

11/09/1995 SUPPL-46 Supplement

Label is not available on this site.

09/29/1995 SUPPL-45 Supplement

Label is not available on this site.

03/09/1995 SUPPL-44 Supplement

Label is not available on this site.

02/22/1995 SUPPL-43 Supplement

Label is not available on this site.

03/31/1994 SUPPL-42 Supplement

Label is not available on this site.

12/07/1992 SUPPL-41 Supplement

Label is not available on this site.

05/10/1993 SUPPL-40 Supplement

Label is not available on this site.

06/14/1994 SUPPL-39 Supplement

Label is not available on this site.

01/27/1992 SUPPL-38 Supplement

Label is not available on this site.

01/11/1994 SUPPL-37 Supplement

Label is not available on this site.

03/12/1991 SUPPL-36 Supplement

Label is not available on this site.

11/15/1991 SUPPL-35 Supplement

Label is not available on this site.

09/24/1990 SUPPL-34 Supplement

Label is not available on this site.

08/17/1990 SUPPL-33 Supplement

Label is not available on this site.

01/23/1989 SUPPL-32 Supplement

Label is not available on this site.

07/29/1988 SUPPL-31 Supplement

Label is not available on this site.

02/01/1989 SUPPL-30 Supplement

Label is not available on this site.

03/24/1988 SUPPL-29 Supplement

Label is not available on this site.

10/27/1987 SUPPL-28 Supplement

Label is not available on this site.

06/10/1988 SUPPL-27 Supplement

Label is not available on this site.

07/10/1987 SUPPL-26 Supplement

Label is not available on this site.

05/28/1986 SUPPL-24 Supplement

Label is not available on this site.

07/13/1987 SUPPL-23 Supplement

Label is not available on this site.

05/07/1987 SUPPL-22 Supplement

Label is not available on this site.

07/28/1987 SUPPL-21 Supplement

Label is not available on this site.

09/15/1986 SUPPL-20 Supplement

Label is not available on this site.

04/10/1986 SUPPL-18 Supplement

Label is not available on this site.

03/08/1985 SUPPL-16 Supplement

Label is not available on this site.

11/23/1984 SUPPL-14 Supplement

Label is not available on this site.

12/26/1984 SUPPL-13 Supplement

Label is not available on this site.

02/28/1984 SUPPL-12 Supplement

Label is not available on this site.

01/26/1984 SUPPL-11 Supplement

Label is not available on this site.

07/25/1984 SUPPL-9 Supplement

Label is not available on this site.

10/12/1983 SUPPL-8 Supplement

Label is not available on this site.

08/24/1983 SUPPL-7 Supplement

Label is not available on this site.

03/14/1983 SUPPL-5 Supplement

Label is not available on this site.

01/27/1983 SUPPL-4 Supplement

Label is not available on this site.

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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-176 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf

HUMULIN R

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 R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019938 NOVO NORDISK INC

HUMULIN R

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 R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019938 NOVO NORDISK INC

HUMULIN R KWIKPEN

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

HUMULIN R 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; 100 UNITS/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HUMULIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019938 NOVO NORDISK INC

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