Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077260
Company: TEVA PARENTERAL

Products on ANDA 077260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE; INJECTION	Prescription	AP	No	No
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE; INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2008	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
11/22/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077260

IRINOTECAN HYDROCHLORIDE

INJECTABLE; INJECTION; 40MG/2ML (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	40MG/2ML (20MG/ML)	INJECTABLE; INJECTION	Prescription	No	AP	077260	TEVA PARENTERAL

INJECTABLE; INJECTION; 100MG/5ML (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	100MG/5ML (20MG/ML)	INJECTABLE; INJECTION	Prescription	No	AP	077260	TEVA PARENTERAL