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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022453
Company: MEITHEAL

Summary Review

Products on NDA 022453

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	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2012	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/2012/022453s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022453Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022453s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022453Orig1s011ltr.pdf
09/20/2017	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022453Orig1s010ltr.pdf
11/14/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/21/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/29/2016	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022453Orig1s007ltr.pdf
03/30/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/23/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/23/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/28/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022453Orig1s002ltr.pdf
10/03/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022453

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022453s011lbl.pdf
09/20/2017	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf
01/29/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf
02/28/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf
12/20/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022453s000lbl.pdf

Therapeutic Equivalents for NDA 022453

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
TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	022453	MEITHEAL

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