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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020623
Company: VALIDUS PHARMS

Products on NDA 020623

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANZEMET	DOLASETRON MESYLATE	50MG	TABLET;ORAL	Discontinued	None	Yes	No
ANZEMET	DOLASETRON MESYLATE	100MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020623

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020623_anzemet_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020623s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020623Orig1s012ltr.pdf
08/06/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/16/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020623Orig1s010,020624Orig1s023ltr.pdf
09/22/2011	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020623s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020623s009ltr.pdf
10/06/2009	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020623s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020623s008ltr.pdf
09/24/2007	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s007, 020624s017ltr.pdf
05/30/2007	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s006,020624s016ltr.pdf
06/01/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020623s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020623s004ltr.pdf
03/16/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/25/1999	SUPPL-2	Labeling		Label is not available on this site.
10/17/1997	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020623

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020623s012lbl.pdf
09/16/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf
09/22/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020623s009lbl.pdf
10/06/2009	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020623s008lbl.pdf
05/30/2007	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf
06/01/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020623s004lbl.pdf

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