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FDA ANDA · ANDA078122

IRINOTECAN HYDROCHLORIDE

Sponsor: PLIVA LACHEMA

APPLICATION
ANDA078122
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-31
LATEST ACTION
2008-10-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2008-10-31OriginalAP
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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