Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020624
Company: US PHARM HOLDINGS
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
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.

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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