Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200582
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP 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
02/02/2011 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/2011/200582s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200582s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200582Orig1s002ltr.pdf
02/28/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200582s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200582Origs001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf
02/28/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200582s001lbl.pdf
02/02/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200582s000lbl.pdf

TOPOTECAN HYDROCHLORIDE

SOLUTION;INTRAVENOUS; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 204406 ACCORD HLTHCARE
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 200582 HOSPIRA INC
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 206074 MYLAN LABS LTD
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 022453 TEVA PHARMS USA

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