Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020981
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 0.25MG BASE CAPSULE;ORAL Prescription None Yes No
HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/11/2007 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020981s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981_hycamtin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/05/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020981s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020981Orig1s008Ltr.pdf
06/18/2014 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020981s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020981Orig1s006ltr.pdf
10/07/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020981s005ltr.pdf
06/30/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020981s002ltr.pdf
09/05/2008 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/05/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020981s008lbl.pdf
06/18/2014 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020981s006lbl.pdf
10/07/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf
06/30/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf
10/11/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf

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