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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200582
Company: HOSPIRA INC

Summary Review

Products on NDA 200582

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	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200582

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2011	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/2011/200582s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200582s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582_topotecan_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200582Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200582s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200582Orig1s003ltr.pdf
01/29/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200582Orig1s002ltr.pdf
02/28/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200582s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200582Origs001ltr.pdf

Labels for NDA 200582

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200582s003lbl.pdf
01/29/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200582s002lbl.pdf
02/28/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200582s001lbl.pdf
02/02/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200582s000lbl.pdf

Therapeutic Equivalents for NDA 200582

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

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