Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022214
Company: ASTRAZENECA

Products on NDA 022214

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARIMIDEX	ANASTROZOLE	1MG	TABLET; ORAL	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022214

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2008	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022214s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022214_arimidex_toc.cfm

Therapeutic Equivalents for NDA 022214

ARIMIDEX

There are no Therapeutic Equivalents.