← FDA DRUG APPROVALS

FDA ANDA · ANDA203380

IRINOTECAN HYDROCHLORIDE

Sponsor: QILU PHARM HAINAN

APPLICATION
ANDA203380
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-03
LATEST ACTION
2020-06-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION

Approval history

2020-06-03Labeling · Supplement 3 · standardAP
2020-06-03Labeling · Supplement 4 · standardAP
2016-05-03UNKNOWN · Original — Letter ↗AP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →