Drugs@FDA: FDA-Approved Drugs

Biologic License Application (BLA): 019717
Company: LILLY

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

Products on BLA 019717

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

Showing 1 to 2 of 2 entries

Approval Date(s) and History, Letters, Labels, Reviews for BLA 019717

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
04/25/1989	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-174	Supplement	Label (PDF) Letter (PDF)
11/15/2019	SUPPL-169	Supplement	Label (PDF) Letter (PDF)
11/15/2019	SUPPL-168	Supplement	Label (PDF) Letter (PDF)
08/22/2019	SUPPL-165	Supplement	Label (PDF) Letter (PDF)
11/06/2018	SUPPL-161	Supplement	Label (PDF) Letter (PDF)
01/06/2017	SUPPL-146	Supplement	Label (PDF) Letter (PDF)
03/12/2015	SUPPL-135	Supplement	Label (PDF) Letter (PDF)
02/25/2015	SUPPL-133	Supplement	Label (PDF) Letter (PDF)
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.
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.
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.
01/24/2014	SUPPL-120	Supplement		Label is not available on this site.
01/15/2014	SUPPL-124	Supplement	Letter (PDF)	Label is not available on this site.
12/12/2013	SUPPL-116	Supplement		Label is not available on this site.
12/09/2013	SUPPL-123	Supplement	Letter (PDF)	Label is not available on this site.
11/07/2013	SUPPL-101	Supplement	Label (PDF) Letter (PDF)
11/07/2013	SUPPL-98	Supplement	Label (PDF) Letter (PDF)
08/21/2013	SUPPL-111	Supplement		Label is not available on this site.
08/15/2013	SUPPL-115	Supplement		Label is not available on this site.
06/12/2013	SUPPL-105	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.
05/10/2013	SUPPL-108	Supplement		Label is not available on this site.
03/09/2013	SUPPL-99	Supplement	Label (PDF) Letter (PDF)
02/15/2013	SUPPL-107	Supplement		Label is not available on this site.
03/21/2012	SUPPL-93	Supplement		Label is not available on this site.
06/10/2010	SUPPL-94	Supplement	Label (PDF) Letter (PDF)
03/16/2009	SUPPL-87	Supplement	Letter (PDF)	Label is not available on this site.
09/07/2007	SUPPL-68	Supplement	Letter (PDF)	Label is not available on this site.
08/22/2007	SUPPL-69	Supplement	Label (PDF) Letter (PDF)
11/09/2005	SUPPL-65	Supplement		Label is not available on this site.
11/10/2004	SUPPL-60	Supplement	Label (PDF) Letter (PDF)
04/23/2004	SUPPL-58	Supplement	Label (PDF) Letter (PDF)
11/19/2003	SUPPL-54	Supplement	Label (PDF) Letter (PDF)
11/17/2003	SUPPL-50	Supplement	Label (PDF) Letter (PDF)
06/22/2003	SUPPL-52	Supplement	Label (PDF) Letter (PDF)
02/12/2003	SUPPL-32	Supplement	Label (PDF) Letter (PDF)
11/01/2002	SUPPL-30	Supplement	Letter (PDF)	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 (PDF) Letter (PDF)
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.
04/02/2002	SUPPL-36	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.
02/05/2002	SUPPL-35	Supplement	Letter (PDF)	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.
02/20/1998	SUPPL-24	Supplement		Label is not available on this site.
07/16/1997	SUPPL-25	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.
07/26/1996	SUPPL-19	Supplement		Label is not available on this site.
07/10/1996	SUPPL-20	Supplement		Label is not available on this site.
05/31/1996	SUPPL-17	Supplement		Label is not available on this site.
05/22/1996	SUPPL-18	Supplement		Label is not available on this site.
02/15/1996	SUPPL-15	Supplement		Label is not available on this site.
01/26/1996	SUPPL-16	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.
02/23/1994	SUPPL-8	Supplement		Label is not available on this site.
01/11/1994	SUPPL-6	Supplement		Label is not available on this site.
12/07/1992	SUPPL-9	Supplement		Label is not available on this site.
01/27/1992	SUPPL-7	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.
05/23/1990	SUPPL-2	Supplement		Label is not available on this site.
04/22/1990	SUPPL-3	Supplement		Label is not available on this site.
05/26/1989	SUPPL-1	Supplement		Label is not available on this site.

Showing 1 to 81 of 81 entries

Labels for BLA 019717

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/27/2022	SUPPL-174	Labeling-Container/Carton Labels	Label (PDF)
06/27/2022	SUPPL-174	Labeling-Package Insert	Label (PDF)
06/27/2022	SUPPL-174	Labeling-Patient Package Insert	Label (PDF)
11/15/2019	SUPPL-169	Labeling-Package Insert	Label (PDF)
11/15/2019	SUPPL-168	Labeling-Package Insert	Label (PDF)
11/15/2019	SUPPL-168	Labeling-Container/Carton Labels	Label (PDF)
08/22/2019	SUPPL-165	Labeling-Package Insert	Label (PDF)
08/22/2019	SUPPL-165	Labeling-Patient Package Insert	Label (PDF)
08/22/2019	SUPPL-165	Labeling-Container/Carton Labels	Label (PDF)
11/06/2018	SUPPL-161	Labeling-Package Insert	Label (PDF)
01/06/2017	SUPPL-146	Labeling-Package Insert	Label (PDF)
03/12/2015	SUPPL-135	Labeling-Package Insert	Label (PDF)
02/25/2015	SUPPL-133	Labeling-Container/Carton Labels	Label (PDF)
02/25/2015	SUPPL-133	Labeling-Patient Package Insert	Label (PDF)
11/07/2013	SUPPL-101	Labeling-Package Insert	Label (PDF)
11/07/2013	SUPPL-98	Labeling-Container/Carton Labels	Label (PDF)
03/09/2013	SUPPL-99	Labeling-Package Insert	Label (PDF)
03/09/2013	SUPPL-99	Labeling-Patient Package Insert	Label (PDF)
06/10/2010	SUPPL-94	Labeling-Patient Package Insert	Label (PDF)
08/22/2007	SUPPL-69	Labeling	Label (PDF)
11/10/2004	SUPPL-60	Labeling	Label (PDF)
04/23/2004	SUPPL-58	Labeling	Label (PDF)
11/19/2003	SUPPL-54	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.
11/17/2003	SUPPL-50	Labeling	Label (PDF)
06/22/2003	SUPPL-52	Labeling	Label (PDF)
02/12/2003	SUPPL-32	Labeling	Label (PDF)
10/03/2002	SUPPL-41	Labeling	Label (PDF)

Showing 1 to 27 of 27 entries

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

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

CSV Excel Print

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

Showing 1 to 3 of 3 entries

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

CSV Excel Print

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

Showing 1 to 3 of 3 entries