Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019991
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVOLIN 70/30 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
06/25/1991 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-82 Supplement

Label is not available on this site.

06/01/2018 SUPPL-79 Supplement

Label is not available on this site.

01/08/2016 SUPPL-77 Supplement

Label is not available on this site.

06/01/2018 SUPPL-75 Supplement

Label is not available on this site.

03/09/2013 SUPPL-74 Supplement

Label is not available on this site.

06/25/2010 SUPPL-72 Supplement

Label is not available on this site.

12/27/2010 SUPPL-71 Supplement

Label is not available on this site.

06/25/2010 SUPPL-70 Supplement

Label is not available on this site.

07/17/2009 SUPPL-68 Supplement

Label is not available on this site.

06/15/2009 SUPPL-67 Supplement

Label is not available on this site.

06/19/2002 SUPPL-39 Supplement

Label is not available on this site.

01/10/2002 SUPPL-38 Supplement

Label is not available on this site.

12/19/2001 SUPPL-37 Supplement

Label is not available on this site.

04/15/2002 SUPPL-36 Supplement

Label is not available on this site.

04/11/2002 SUPPL-35 Supplement

Label is not available on this site.

01/09/2001 SUPPL-34 Supplement

Label is not available on this site.

12/13/2000 SUPPL-33 Supplement

Label is not available on this site.

03/11/2002 SUPPL-32 Supplement

Label is not available on this site.

12/10/2001 SUPPL-31 Supplement

Label is not available on this site.

02/21/2001 SUPPL-30 Supplement

Label is not available on this site.

06/15/2000 SUPPL-29 Supplement

Label is not available on this site.

04/10/2000 SUPPL-28 Supplement

Label is not available on this site.

03/16/2000 SUPPL-27 Supplement

Label is not available on this site.

10/18/1999 SUPPL-26 Supplement

Label is not available on this site.

05/12/1999 SUPPL-25 Supplement

Label is not available on this site.

07/24/1998 SUPPL-24 Supplement

Label is not available on this site.

08/04/1997 SUPPL-23 Supplement

Label is not available on this site.

06/20/1997 SUPPL-22 Supplement

Label is not available on this site.

04/16/1997 SUPPL-21 Supplement

Label is not available on this site.

01/02/1997 SUPPL-20 Supplement

Label is not available on this site.

04/10/1997 SUPPL-19 Supplement

Label is not available on this site.

06/13/1996 SUPPL-18 Supplement

Label is not available on this site.

01/28/1997 SUPPL-17 Supplement

Label is not available on this site.

05/22/1995 SUPPL-16 Supplement

Label is not available on this site.

01/04/1994 SUPPL-15 Supplement

Label is not available on this site.

01/03/1994 SUPPL-14 Supplement

Label is not available on this site.

06/23/1994 SUPPL-13 Supplement

Label is not available on this site.

06/23/1994 SUPPL-12 Supplement

Label is not available on this site.

06/16/1994 SUPPL-11 Supplement

Label is not available on this site.

05/31/1994 SUPPL-10 Supplement

Label is not available on this site.

05/23/1994 SUPPL-9 Supplement

Label is not available on this site.

04/26/1994 SUPPL-8 Supplement

Label is not available on this site.

01/07/1994 SUPPL-7 Supplement

Label is not available on this site.

03/26/1993 SUPPL-6 Supplement

Label is not available on this site.

03/26/1993 SUPPL-4 Supplement

Label is not available on this site.

03/13/1992 SUPPL-2 Supplement

Label is not available on this site.

10/07/1991 SUPPL-1 Supplement

Label is not available on this site.

NOVOLIN 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

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