Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200199
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPOTECAN TOPOTECAN HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No
TOPOTECAN TOPOTECAN HYDROCHLORIDE EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No
TOPOTECAN TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No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
02/25/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200199s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200199Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf
02/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf

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