Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022303
Company: CEPHALON

• Summary Review

Products on NDA 022303

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TREANDA	BENDAMUSTINE HYDROCHLORIDE	100MG	INJECTABLE; INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022303

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2008	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022303lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022303s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022303_treanda_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022303s000_SumR.pdf

Labels for NDA 022303

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022303lbl.pdf