Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020815
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVISTA RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB Yes Yes
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.cfm
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.cfm
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.

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

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 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 INC
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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