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FDA ANDA · ANDA090393

IRINOTECAN HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA090393
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-13
LATEST ACTION
2011-05-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 20MG/ML · INJECTABLE · INJECTION

Approval history

2011-05-13OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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