Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022453
Company: TEVA PHARMS USA
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 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
12/20/2012 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/2012/022453s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022453Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2019 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022453s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022453Orig1s011ltr.pdf
09/20/2017 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022453Orig1s010ltr.pdf
11/14/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/21/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/29/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022453Orig1s007ltr.pdf
03/30/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/23/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/23/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022453Orig1s002ltr.pdf
10/03/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/24/2019 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022453s011lbl.pdf
09/20/2017 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf
01/29/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf
02/28/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf
12/20/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022453s000lbl.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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