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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205004
Company: FRESENIUS KABI USA

Products on NDA 205004

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	POWDER;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205004s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205004Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205004Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205004s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205004Orig1s003ltr.pdf
07/12/2018	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205004Orig1s002Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205004Orig1s002.pdf

Labels for NDA 205004

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205004s003lbl.pdf
07/12/2018	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf
07/12/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf
11/06/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205004s000lbl.pdf

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