Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021526
Company: GILEAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANEXA RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
RANEXA RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/2006 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021526s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021526s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/10/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/06/2016 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021526Orig1s029ltr.pdf
12/15/2015 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021526s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021526Orig1s028ltr.pdf
01/17/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s026ltr.pdf
11/12/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s025ltr.pdf
07/25/2012 SUPPL-22 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021526s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021526Orig1s022ltr.pdf
12/21/2011 SUPPL-18 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s018ltr.pdf
07/11/2011 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s014ltr.pdf
09/23/2010 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021526s012ltr.pdf
03/26/2009 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021526s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021526Orig1s007.pdf
11/05/2008 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021526s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021526s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021526Orig1s004TOC.cfm
12/17/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021526s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/06/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf
12/15/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021526s028lbl.pdf
12/19/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s026lbl.pdf
11/12/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s025lbl.pdf
07/25/2012 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021526s022lbl.pdf
12/21/2011 SUPPL-18 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s018lbl.pdf
07/11/2011 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf
09/23/2010 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf
03/26/2009 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf
11/05/2008 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021526s004lbl.pdf
12/17/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf
01/27/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021526s000lbl.pdf

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