Drugs@FDA: FDA-Approved Drugs

Biologic License Application (BLA): 018781
Company: LILLY

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

Products on BLA 018781

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

Showing 1 to 1 of 1 entries

Approval Date(s) and History, Letters, Labels, Reviews for BLA 018781

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-193	Supplement	Label (PDF) Letter (PDF)
11/15/2019	SUPPL-188	Supplement	Label (PDF) Letter (PDF)
11/15/2019	SUPPL-187	Supplement	Label (PDF) Letter (PDF)
08/22/2019	SUPPL-184	Supplement	Label (PDF) Letter (PDF)
11/06/2018	SUPPL-181	Supplement	Label (PDF) Letter (PDF)
01/06/2017	SUPPL-167	Supplement	Label (PDF) Letter (PDF)
04/22/2016	SUPPL-161	Supplement		Label is not available on this site.
04/05/2016	SUPPL-163	Supplement		Label is not available on this site.
02/19/2016	SUPPL-160	Supplement		Label is not available on this site.
10/20/2015	SUPPL-159	Supplement		Label is not available on this site.
10/08/2015	SUPPL-158	Supplement		Label is not available on this site.
07/15/2015	SUPPL-157	Supplement		Label is not available on this site.
03/12/2015	SUPPL-156	Supplement	Label (PDF) Letter (PDF)
03/03/2015	SUPPL-155	Supplement		Label is not available on this site.
02/25/2015	SUPPL-154	Supplement	Label (PDF) Letter (PDF)
01/12/2015	SUPPL-153	Supplement		Label is not available on this site.
09/30/2014	SUPPL-120	Supplement	Label (PDF)
09/12/2014	SUPPL-150	Supplement		Label is not available on this site.
06/10/2014	SUPPL-146	Supplement		Label is not available on this site.
06/04/2014	SUPPL-147	Supplement		Label is not available on this site.
04/11/2014	SUPPL-143	Supplement		Label is not available on this site.
04/03/2014	SUPPL-142	Supplement		Label is not available on this site.
03/18/2014	SUPPL-140	Supplement		Label is not available on this site.
03/04/2014	SUPPL-139	Supplement		Label is not available on this site.
01/24/2014	SUPPL-141	Supplement		Label is not available on this site.
01/15/2014	SUPPL-145	Supplement	Letter (PDF)	Label is not available on this site.
12/12/2013	SUPPL-137	Supplement		Label is not available on this site.
12/09/2013	SUPPL-144	Supplement	Letter (PDF)	Label is not available on this site.
11/07/2013	SUPPL-122	Supplement	Label (PDF) Letter (PDF)
11/07/2013	SUPPL-118	Supplement	Label (PDF) Letter (PDF)
08/21/2013	SUPPL-132	Supplement		Label is not available on this site.
08/15/2013	SUPPL-136	Supplement		Label is not available on this site.
06/12/2013	SUPPL-126	Supplement		Label is not available on this site.
05/31/2013	SUPPL-134	Supplement		Label is not available on this site.
05/30/2013	SUPPL-133	Supplement		Label is not available on this site.
05/10/2013	SUPPL-129	Supplement		Label is not available on this site.
03/25/2013	SUPPL-130	Supplement		Label is not available on this site.
03/09/2013	SUPPL-121	Supplement	Label (PDF) Letter (PDF)
02/21/2013	SUPPL-131	Supplement		Label is not available on this site.
02/15/2013	SUPPL-128	Supplement		Label is not available on this site.
12/03/2012	SUPPL-125	Supplement		Label is not available on this site.
03/21/2012	SUPPL-113	Supplement		Label is not available on this site.
06/10/2010	SUPPL-114	Supplement	Label (PDF) Letter (PDF)
03/16/2009	SUPPL-108	Supplement	Label (PDF) Letter (PDF)
09/07/2007	SUPPL-88	Supplement	Letter (PDF)	Label is not available on this site.
08/22/2007	SUPPL-89	Supplement	Label (PDF) Letter (PDF)
11/09/2005	SUPPL-85	Supplement	Label (PDF) Letter (PDF)
02/25/2005	SUPPL-80	Supplement	Label (PDF) Letter (PDF)
09/03/2004	SUPPL-79	Supplement	Label (PDF) Letter (PDF)
04/21/2004	SUPPL-76	Supplement	Label (PDF) Letter (PDF)
11/20/2003	SUPPL-70	Supplement	Letter (PDF)	Label is not available on this site.
11/20/2003	SUPPL-60	Supplement	Letter (PDF)	Label is not available on this site.
11/19/2003	SUPPL-74	Supplement	Label (PDF) Letter (PDF)
06/22/2003	SUPPL-72	Supplement	Label (PDF) Letter (PDF)
02/12/2003	SUPPL-57	Supplement	Letter (PDF) Letter (PDF)	Label is not available on this site.
11/05/2002	SUPPL-54	Supplement	Letter (PDF)	Label is not available on this site.
10/31/2002	SUPPL-62	Supplement		Label is not available on this site.
08/29/2002	SUPPL-67	Supplement		Label is not available on this site.
08/29/2002	SUPPL-66	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-64	Supplement		Label is not available on this site.
08/21/2002	SUPPL-63	Supplement		Label is not available on this site.
04/02/2002	SUPPL-61	Supplement		Label is not available on this site.
07/07/2000	SUPPL-56	Supplement		Label is not available on this site.
10/29/1999	SUPPL-55	Supplement		Label is not available on this site.
02/25/1999	SUPPL-53	Supplement		Label is not available on this site.
08/06/1998	SUPPL-50	Supplement		Label is not available on this site.
02/20/1998	SUPPL-48	Supplement		Label is not available on this site.
06/24/1997	SUPPL-49	Supplement		Label is not available on this site.
04/16/1997	SUPPL-47	Supplement		Label is not available on this site.
01/28/1997	SUPPL-46	Supplement		Label is not available on this site.
07/26/1996	SUPPL-43	Supplement		Label is not available on this site.
07/10/1996	SUPPL-44	Supplement		Label is not available on this site.
05/31/1996	SUPPL-41	Supplement		Label is not available on this site.
05/22/1996	SUPPL-42	Supplement		Label is not available on this site.
02/15/1996	SUPPL-39	Supplement		Label is not available on this site.
01/26/1996	SUPPL-40	Supplement		Label is not available on this site.
11/09/1995	SUPPL-38	Supplement		Label is not available on this site.
10/27/1995	SUPPL-33	Supplement		Label is not available on this site.
09/29/1995	SUPPL-37	Supplement		Label is not available on this site.
03/09/1995	SUPPL-36	Supplement		Label is not available on this site.
02/22/1995	SUPPL-35	Supplement		Label is not available on this site.
02/10/1995	SUPPL-34	Supplement		Label is not available on this site.
01/11/1994	SUPPL-31	Supplement		Label is not available on this site.
12/07/1992	SUPPL-32	Supplement		Label is not available on this site.
04/03/1991	SUPPL-27	Supplement	Review (PDF)	Label is not available on this site.
03/12/1991	SUPPL-30	Supplement		Label is not available on this site.
09/24/1990	SUPPL-29	Supplement		Label is not available on this site.
08/17/1990	SUPPL-28	Supplement		Label is not available on this site.
01/23/1989	SUPPL-26	Supplement		Label is not available on this site.
07/29/1988	SUPPL-25	Supplement		Label is not available on this site.
06/28/1988	SUPPL-13	Supplement		Label is not available on this site.
03/24/1988	SUPPL-23	Supplement		Label is not available on this site.
03/03/1988	SUPPL-24	Supplement		Label is not available on this site.
10/27/1987	SUPPL-22	Supplement		Label is not available on this site.
10/27/1987	SUPPL-21	Supplement		Label is not available on this site.
10/27/1987	SUPPL-20	Supplement		Label is not available on this site.
10/27/1987	SUPPL-15	Supplement		Label is not available on this site.
07/31/1987	SUPPL-14	Supplement		Label is not available on this site.
07/28/1987	SUPPL-16	Supplement		Label is not available on this site.
07/13/1987	SUPPL-18	Supplement		Label is not available on this site.
07/13/1987	SUPPL-17	Supplement		Label is not available on this site.
07/10/1987	SUPPL-19	Supplement		Label is not available on this site.
02/14/1985	SUPPL-9	Supplement		Label is not available on this site.
12/26/1984	SUPPL-10	Supplement		Label is not available on this site.
07/25/1984	SUPPL-7	Supplement		Label is not available on this site.
02/29/1984	SUPPL-8	Supplement		Label is not available on this site.
10/12/1983	SUPPL-6	Supplement		Label is not available on this site.
08/24/1983	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 113 of 113 entries

Labels for BLA 018781

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/27/2022	SUPPL-193	Labeling-Package Insert	Label (PDF)
06/27/2022	SUPPL-193	Labeling-Container/Carton Labels	Label (PDF)
06/27/2022	SUPPL-193	Labeling-Patient Package Insert	Label (PDF)
11/15/2019	SUPPL-188	Labeling-Package Insert	Label (PDF)
11/15/2019	SUPPL-187	Labeling-Container/Carton Labels	Label (PDF)
11/15/2019	SUPPL-187	Labeling-Package Insert	Label (PDF)
08/22/2019	SUPPL-184	Labeling-Container/Carton Labels	Label (PDF)
08/22/2019	SUPPL-184	Labeling-Patient Package Insert	Label (PDF)
08/22/2019	SUPPL-184	Labeling-Package Insert	Label (PDF)
11/06/2018	SUPPL-181	Labeling-Package Insert	Label (PDF)
01/06/2017	SUPPL-167	Labeling-Package Insert	Label (PDF)
03/12/2015	SUPPL-156	Labeling-Package Insert	Label (PDF)
02/25/2015	SUPPL-154	Labeling-Patient Package Insert	Label (PDF)
02/25/2015	SUPPL-154	Labeling-Container/Carton Labels	Label (PDF)
09/30/2014	SUPPL-120	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.
11/07/2013	SUPPL-122	Labeling-Package Insert	Label (PDF)
11/07/2013	SUPPL-118	Labeling-Container/Carton Labels	Label (PDF)
03/09/2013	SUPPL-121	Labeling	Label (PDF)
06/10/2010	SUPPL-114	Labeling-Patient Package Insert	Label (PDF)
03/16/2009	SUPPL-108	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.
08/22/2007	SUPPL-89	Labeling	Label (PDF)
11/09/2005	SUPPL-85	Labeling	Label (PDF)
02/25/2005	SUPPL-80	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.
09/03/2004	SUPPL-79	Labeling	Label (PDF)
04/21/2004	SUPPL-76	Labeling	Label (PDF)
11/19/2003	SUPPL-74	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.
06/22/2003	SUPPL-72	Labeling	Label (PDF)

Showing 1 to 27 of 27 entries

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

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

CSV Excel Print

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

Showing 1 to 2 of 2 entries