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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 208751
Company: NOVO

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 208751

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	No	No
FIASP FLEXTOUCH	INSULIN ASPART	300 UNITS/3ML (100 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No
FIASP PENFILL	INSULIN ASPART	300 UNITS/3ML (100 UNITS/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 208751

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		N/A	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
06/21/2023	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208751Orig1s020ltr.pdf
10/21/2019	SUPPL-13	Supplement	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	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s012ltr.pdf
12/19/2019	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s010, s011ltr.pdf
12/19/2019	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208751Orig1s010, s011ltr.pdf
10/21/2019	SUPPL-8	Supplement	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	Supplement		Label is not available on this site.
09/24/2018	SUPPL-3	Supplement		Label is not available on this site.
07/22/2018	SUPPL-2	Supplement		Label is not available on this site.
03/06/2018	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 208751

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2023	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf
06/21/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf
06/21/2023	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208751s020lbl.pdf
12/19/2019	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf
12/19/2019	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208751s010s011lbl.pdf
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
09/29/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf

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