Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090101
Company: TEVA PHARMS USA

Products on ANDA 090101

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	500MG/25ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090101

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2008	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
04/29/2013	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/29/2013	SUPPL-17	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090101

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION; 500MG/25ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	500MG/25ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078589	ACTAVIS TOTOWA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	500MG/25ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213278	EUGIA PHARMA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	500MG/25ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078796	HOSPIRA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	500MG/25ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090101	TEVA PHARMS USA