Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020623
Company: US PHARM HOLDINGS
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
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.cfm
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.

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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