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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 203313
Company: NOVO

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

Products on BLA 203313

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 203313

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		N/A	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
10/06/2022	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203313Orig1s014ltr.pdf
11/15/2019	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203313Orig1s009, s010ltr.pdf
11/15/2019	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203313Orig1s009, s010ltr.pdf
08/09/2018	SUPPL-5	Supplement	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	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s004lbl.pdf
06/24/2016	SUPPL-3	Supplement		Label is not available on this site.
12/16/2016	SUPPL-2	Supplement	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	Supplement		Label is not available on this site.

Labels for BLA 203313

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2022	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf
10/06/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf
10/06/2022	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf
11/15/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf
11/15/2019	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf
11/15/2019	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf
11/15/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf
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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