Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020671
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION 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
05/28/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020671Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2019 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020671s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020671Orig1s024ltr.pdf
09/05/2018 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020671s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020671Orig1s23Ltr.pdf
06/02/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020671Orig1s021ltr.pdf
02/28/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020671s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020671Orig1s020ltr.pdf
03/26/2010 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020671s016,s017ltr.pdf
03/26/2010 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020671s016,s017ltr.pdf
06/14/2006 SUPPL-14 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020671s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020671s014LTR.pdf
05/09/2003 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20671slr012_hycamtin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671slr012ltr.pdf
03/11/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671slr011ltr.pdf
02/26/2003 SUPPL-10 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

03/06/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20671s9ltr.pdf
08/03/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/30/1998 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20671s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20671s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20671s004.cfm
02/04/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/08/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020671s024lbl.pdf
09/05/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020671s023lbl.pdf
06/02/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf
02/28/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020671s020lbl.pdf
03/26/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf
03/26/2010 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf
06/14/2006 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020671s014lbl.pdf
05/09/2003 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20671slr012_hycamtin_lbl.pdf
11/30/1998 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20671s4lbl.pdf

HYCAMTIN

INJECTABLE;INJECTION; EQ 4MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020671 NOVARTIS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202351 ACCORD HLTHCARE
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090620 ACTAVIS TOTOWA
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091199 CIPLA
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201191 DR REDDYS LABS LTD
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091089 FRESENIUS KABI USA
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201166 HONG KONG
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206962 NOVAST LABS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091284 SAGENT PHARMS

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