Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078796
Company: HOSPIRA
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 Yes
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
12/27/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/02/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/24/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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 078796 HOSPIRA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090101 TEVA PHARMS USA

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