Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022310
Company: ASTRAZENECA

Products on NDA 022310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CASODEX	BICALUTAMIDE	50MG	TABLET; ORAL	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2008	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022310s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022310_casodex_toc.cfm

Labels for NDA 022310

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022310lbl.pdf

Therapeutic Equivalents for NDA 022310

CASODEX

There are no Therapeutic Equivalents.