Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208751
Company: NOVO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIASP INSULIN ASPART 1000 UNITS/10ML (100 UNITS/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes Yes
FIASP FLEXTOUCH INSULIN ASPART 300 UNITS/3ML (100 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
FIASP PENFILL INSULIN ASPART 300 UNITS/3ML (100 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
09/29/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208751Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208751Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/21/2019 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s008, s013ltr.pdf
11/15/2019 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf
10/21/2019 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s008, s013ltr.pdf
09/04/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208751Orig1s005ltr.pdf
09/24/2018 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208751Orig1s003ltr.pdf
07/22/2018 SUPPL-2 Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
03/06/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208751Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/15/2019 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf
11/15/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf
10/21/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf
10/21/2019 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s008s013lbl.pdf
09/04/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s005lbl.pdf
03/06/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208751s001lbl.pdf
09/29/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf

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