Drugs@FDA: FDA Approved Drug Products

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

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

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