Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021991
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLINZA VORINOSTAT 100MG CAPSULE;ORAL Prescription None 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
10/06/2006 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021991lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021991s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021991s000_ZolinzaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021991s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021991Orig1s009ltr.pdf
12/17/2015 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021991Orig1s008ltr.pdf
10/07/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/24/2013 SUPPL-6 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

06/10/2011 SUPPL-5 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
09/23/2009 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021991s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021991s004ltr.pdf
11/14/2011 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021991s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021991s002ltr.pdf
07/22/2008 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021991s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021991s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/11/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021991s009lbl.pdf
11/14/2011 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021991s002lbl.pdf
09/23/2009 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021991s004lbl.pdf
07/22/2008 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021991s001lbl.pdf
10/06/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021991lbl.pdf

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