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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090620
Company: ACTAVIS TOTOWA

Products on ANDA 090620

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 090620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/13/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/28/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/28/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/28/2015	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/30/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/08/2011	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090620

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	INGENUS PHARMS LLC
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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