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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020671
Company: SANDOZ

PEDIATRIC STUDIES

Products on NDA 020671

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020671

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.

Labels for NDA 020671

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

Therapeutic Equivalents for NDA 020671

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	SANDOZ
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	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	206962	NOVAST LABS
TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091284	SAGENT PHARMS
TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091199	TEYRO LABS

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