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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020624
Company: VALIDUS PHARMS

Products on NDA 020624

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANZEMET	DOLASETRON MESYLATE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ANZEMET	DOLASETRON MESYLATE	12.5MG/0.625ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ANZEMET	DOLASETRON MESYLATE	500MG/25ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020624

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 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020624_anzemet_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2014	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020624s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020624Orig1s025ltr.pdf
09/20/2013	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/16/2013	SUPPL-23	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-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020624s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020624s022ltr.pdf
10/06/2009	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020624s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020624s020ltr.pdf
09/24/2007	SUPPL-17	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-16	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-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020624s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020624s013ltr.pdf
07/18/2003	SUPPL-9	Manufacturing (CMC)-Control	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20624scs009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020624_S009_ANZEMET.pdf
03/22/2002	SUPPL-8	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20624s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020624_S008_AMZEMET_AP.pdf
05/24/2002	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/11/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/26/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/26/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/13/2003	SUPPL-3	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20624scf003ltr.pdf
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 020624

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2014	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020624s025lbl.pdf
09/16/2013	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf
09/22/2011	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020624s022lbl.pdf
10/06/2009	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020624s020lbl.pdf
05/30/2007	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf
06/01/2005	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020624s013lbl.pdf

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