Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020815
Company: LILLY

• Medication Guide

Products on NDA 20815

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVISTA	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020815

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2018	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020815s034lbl.pdf
07/17/2007	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf
09/30/1999	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf