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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091089
Company: FRESENIUS KABI USA

Products on ANDA 091089

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091089

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091089s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/26/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/26/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091089

TOPOTECAN HYDROCHLORIDE

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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