Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200199
Company: SANDOZ INC

• Summary Review

Products on NDA 200199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPOTECAN	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
TOPOTECAN	TOPOTECAN HYDROCHLORIDE	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
TOPOTECAN	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200199

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2011	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/2011/200199s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200199s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2014	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200199Orig1s003ltr.pdf

Labels for NDA 200199

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf
02/25/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf