Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203313
Company: NOVO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYZODEG 70/30 INSULIN ASPART; INSULIN DEGLUDEC 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/25/2015 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203313Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2018 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203313s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203313Orig1s005ltr.pdf
06/24/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s004lbl.pdf
06/24/2016 SUPPL-3 Labeling

Label is not available on this site.

12/16/2016 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203313Orig1s002ltr.pdf
03/07/2016 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2018 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203313s000lbl.pdf
12/16/2016 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s002lbl.pdf
06/24/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s004lbl.pdf
09/25/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf

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