Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204406
Company: ACCORD HLTHCARE

Products on ANDA 204406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	No
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 ANDA 204406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2017	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204406

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