Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207949
Company: ACCORD HLTHCARE

Products on NDA 207949

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CABAZITAXEL	CABAZITAXEL	60MG/3ML (20MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207949

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207949Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/207949Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207949s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207949Orig1s002ltr.pdf

Labels for NDA 207949

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207949s002lbl.pdf
10/10/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207949s002lbl.pdf