An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021991
Company: MSD SUB MERCK

Products on NDA 021991

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLINZA	VORINOSTAT	100MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021991

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

Labels for NDA 021991

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

Top