Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021991
Company: MSD SUB MERCK
Company: MSD SUB 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-Patient Package Insert, Labeling-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 |