Drugs@FDA: FDA-Approved Drugs

Biologic License Application (BLA): 018780
Company: LILLY

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 018780

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

Showing 1 to 4 of 4 entries

Approval Date(s) and History, Letters, Labels, Reviews for BLA 018780

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
10/28/1982	ORIG-1	Approval		N/A		Label is not available on this site.

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/27/2022	SUPPL-180	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100
11/15/2019	SUPPL-176	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100 and U-500
11/15/2019	SUPPL-175	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100 and U-500
08/22/2019	SUPPL-172	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100 and U-500
11/06/2018	SUPPL-168	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100 and U-500
05/25/2018	SUPPL-134	Supplement	Letter (PDF)	Label for HUMULIN R U-100 Label is not available on this site.
05/25/2018	SUPPL-126	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100
07/08/2016	SUPPL-153	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-500
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.
12/29/2015	SUPPL-152	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-500
12/29/2015	SUPPL-135	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-500
10/08/2015	SUPPL-151	Supplement		Label is not available on this site.
02/25/2015	SUPPL-150	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100
10/30/2014	SUPPL-149	Supplement		Label is not available on this site.
09/23/2014	SUPPL-148	Supplement	Label (PDF)	Label for HUMULIN R U-500
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.
03/09/2013	SUPPL-132	Supplement	Label (PDF) Letter (PDF)	Label for HUMULIN R U-100
01/09/2013	SUPPL-139	Supplement		Label is not available on this site.
11/07/2012	SUPPL-141	Supplement		Label is not available on this site.
03/29/2012	SUPPL-127	Supplement		Label is not available on this site.
10/30/2011	SUPPL-133	Supplement	Letter (PDF)	Label is not available on this site.
03/25/2011	SUPPL-120	Supplement	Label (PDF) Letter (PDF)
03/21/2011	SUPPL-124	Supplement	Letter (PDF)	Label is not available on this site.
06/10/2010	SUPPL-128	Supplement	Label (PDF) Letter (PDF)
09/10/2007	SUPPL-114	Supplement	Label (PDF) Letter (PDF)
09/07/2007	SUPPL-94	Supplement	Letter (PDF)	Label is not available on this site.
08/22/2007	SUPPL-95	Supplement	Label (PDF) Letter (PDF)
02/25/2005	SUPPL-86	Supplement	Label (PDF) Letter (PDF)
11/10/2003	SUPPL-80	Supplement	Label (PDF) Letter (PDF)
04/14/2003	SUPPL-66	Supplement	Letter (PDF)	Label is not available on this site.
02/10/2003	SUPPL-78	Supplement	Label (PDF) Letter (PDF)
02/10/2003	SUPPL-67	Supplement	Label (PDF) Letter (PDF)
10/25/2002	SUPPL-76	Supplement		Label is not available on this site.
10/10/2002	SUPPL-70	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.
08/29/2002	SUPPL-65	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.
03/13/2002	SUPPL-69	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.
07/26/1996	SUPPL-50	Supplement		Label is not available on this site.
07/10/1996	SUPPL-51	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.
06/14/1994	SUPPL-39	Supplement		Label is not available on this site.
03/31/1994	SUPPL-42	Supplement		Label is not available on this site.
01/11/1994	SUPPL-37	Supplement	Review (PDF)	Label is not available on this site.
05/10/1993	SUPPL-40	Supplement		Label is not available on this site.
12/07/1992	SUPPL-41	Supplement		Label is not available on this site.
01/27/1992	SUPPL-38	Supplement		Label is not available on this site.
11/15/1991	SUPPL-35	Supplement		Label is not available on this site.
03/12/1991	SUPPL-36	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.
02/01/1989	SUPPL-30	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.
06/10/1988	SUPPL-27	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.
07/28/1987	SUPPL-21	Supplement		Label is not available on this site.
07/13/1987	SUPPL-23	Supplement		Label is not available on this site.
07/10/1987	SUPPL-26	Supplement		Label is not available on this site.
05/07/1987	SUPPL-22	Supplement		Label is not available on this site.
09/15/1986	SUPPL-20	Supplement		Label is not available on this site.
05/28/1986	SUPPL-24	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.
12/26/1984	SUPPL-13	Supplement		Label is not available on this site.
11/23/1984	SUPPL-14	Supplement		Label is not available on this site.
07/25/1984	SUPPL-9	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.
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.
01/31/1983	SUPPL-3	Supplement		Label is not available on this site.
01/27/1983	SUPPL-4	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.

Showing 1 to 101 of 101 entries

Labels for BLA 018780

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/27/2022	SUPPL-180	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-100
06/27/2022	SUPPL-180	Labeling-Container/Carton Labels	Label (PDF)	Label for HUMULIN R U-100
06/27/2022	SUPPL-180	Labeling-Patient Package Insert	Label (PDF)	Label for HUMULIN R U-100
11/15/2019	SUPPL-176	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-100 and U-500
11/15/2019	SUPPL-175	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-100 and U-500
11/15/2019	SUPPL-175	Labeling-Container/Carton Labels	Label (PDF)	Label for HUMULIN R U-100 and U-500
08/22/2019	SUPPL-172	Labeling-Container/Carton Labels	Label (PDF)	Label for HUMULIN R U-100 and U-500
08/22/2019	SUPPL-172	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-100 and U-500
08/22/2019	SUPPL-172	Labeling-Patient Package Insert	Label (PDF)	Label for HUMULIN R U-100 and U-500
11/06/2018	SUPPL-168	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-100 and U-500
05/25/2018	SUPPL-126	Manufacturing (CMC)	Label (PDF)	Label for HUMULIN R U-100
07/08/2016	SUPPL-153	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-500
07/08/2016	SUPPL-153	Labeling-Container/Carton Labels	Label (PDF)	Label for HUMULIN R U-500
12/29/2015	SUPPL-152	Labeling-Container/Carton Labels	Label (PDF)	Label for HUMULIN R U-500
12/29/2015	SUPPL-152	Labeling-Patient Package Insert	Label (PDF)	Label for HUMULIN R U-500
12/29/2015	SUPPL-152	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-500
12/29/2015	SUPPL-135	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-500
02/25/2015	SUPPL-150	Labeling-Patient Package Insert	Label (PDF)	Label for HUMULIN R U-100
02/25/2015	SUPPL-150	Labeling-Container/Carton Labels	Label (PDF)	Label for HUMULIN R U-100
09/23/2014	SUPPL-148	Manufacturing (CMC)	Label (PDF)	Label for HUMULIN R U-500 This supplement type does not usually require new labeling.
03/09/2013	SUPPL-132	Labeling-Patient Package Insert	Label (PDF)	Label for HUMULIN R U-100
03/09/2013	SUPPL-132	Labeling-Package Insert	Label (PDF)	Label for HUMULIN R U-100
03/25/2011	SUPPL-120	Efficacy-New Route Of Administration	Label (PDF)
06/10/2010	SUPPL-128	Labeling-Patient Package Insert	Label (PDF)
09/10/2007	SUPPL-114	Labeling	Label (PDF)
08/22/2007	SUPPL-95	Labeling	Label (PDF)
02/25/2005	SUPPL-86	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.
11/10/2003	SUPPL-80	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.
02/10/2003	SUPPL-78	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.
02/10/2003	SUPPL-67	Labeling	Label (PDF)

Showing 1 to 30 of 30 entries

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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

CSV Excel Print

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

Showing 1 to 3 of 3 entries

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

CSV Excel Print

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

Showing 1 to 3 of 3 entries

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

CSV Excel Print

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

Showing 1 to 3 of 3 entries