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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020981
Company: SANDOZ

Summary Review

Products on NDA 020981

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYCAMTIN	TOPOTECAN HYDROCHLORIDE	EQ 0.25MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
HYCAMTIN	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020981

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2007	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020981s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981_hycamtin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020981s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020981s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020981Orig1s008Ltr.pdf
06/18/2014	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020981s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020981Orig1s006ltr.pdf
10/07/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020981s005ltr.pdf
06/30/2010	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020981s002ltr.pdf
09/05/2008	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for NDA 020981

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020981s008lbl.pdf
06/18/2014	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020981s006lbl.pdf
10/07/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020981s005lbl.pdf
06/30/2010	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020981s002lbl.pdf
10/11/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020981lbl.pdf

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