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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020815
Company: LILLY

Medication Guide

Products on NDA 020815

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020815

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020815_evista_toc.html

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020815s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020815Orig1s034ltr.pdf
01/25/2016	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
01/11/2016	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
09/13/2007	SUPPL-25	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022042s000,020815s025ltr.pdf
07/17/2007	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020815s018ltr.pdf
12/24/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/2002	SUPPL-10	Labeling		Label is not available on this site.
01/17/2002	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/02/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/13/2000	SUPPL-7	Labeling		Label is not available on this site.
06/27/2000	SUPPL-6	Labeling		Label is not available on this site.
06/23/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/09/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
09/30/1999	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20815s03ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista.html
11/24/1998	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20815s2_Evista.pdf
10/26/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

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

Therapeutic Equivalents for NDA 020815

EVISTA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVISTA	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	Yes	AB	020815	LILLY
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	208206	AMNEAL PHARMS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	204310	AUROBINDO PHARMA
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	211324	CADILA PHARMS LTD
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	204491	GLENMARK PHARMS LTD
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	090842	INVAGEN PHARMS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	206384	SCIEGEN PHARMS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	078193	TEVA PHARMS USA
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	200825	WATSON LABS INC

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