Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018623
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NPH PURIFIED PORK ISOPHANE INSULIN INSULIN SUSP ISOPHANE PURIFIED PORK 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
07/30/1981 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
04/16/1997 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018623ap.pdf
01/02/1997 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1997 SUPPL-25 Labeling

Label is not available on this site.

03/08/1995 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1995 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1995 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1995 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1994 SUPPL-20 Labeling

Label is not available on this site.

01/03/1994 SUPPL-19 Labeling

Label is not available on this site.

01/07/1994 SUPPL-18 Labeling

Label is not available on this site.

12/07/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1992 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1991 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1990 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1986 SUPPL-9 Labeling

Label is not available on this site.

08/28/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1985 SUPPL-7 Labeling

Label is not available on this site.

06/14/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1984 SUPPL-4 Labeling

Label is not available on this site.

09/26/1983 SUPPL-3 Labeling

Label is not available on this site.

10/23/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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