Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021028
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VELOSULIN BR INSULIN 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
07/19/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021028A_Velosulin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2004 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21028slr005_velosulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21028slr005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/24/2004 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21028slr005_velosulin_lbl.pdf
07/19/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21028lbl.pdf

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