Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019965
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVOLIN L INSULIN ZINC SUSP RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Discontinued 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 Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2003 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19965slr024_novolin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19965slr024ltr.pdf
01/10/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1997 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1997 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019965ap.pdf
04/10/1997 SUPPL-16 Labeling

Label is not available on this site.

01/28/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1995 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1994 SUPPL-13 Labeling

Label is not available on this site.

01/03/1994 SUPPL-12 Labeling

Label is not available on this site.

06/23/1994 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/23/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1994 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1994 SUPPL-5 Labeling

Label is not available on this site.

03/26/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2003 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19965slr024_novolin_lbl.pdf

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