← FDA DRUG APPROVALS

FDA BLA · BLA103608

PROSTASCINT

Sponsor: CYTOGEN

APPLICATION
BLA103608
TYPE
BLA
ORIGINAL APPROVAL
1996-10-28
LATEST ACTION
2012-06-26
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

PROSTASCINTPrescription
CAPROMAB PENDETIDE 05.MG/ML · VIAL · INTRAVENOUS

Approval history

2012-06-26Supplement · Supplement 5043LabelAP
1996-10-28Type 1 - New Molecular Entity · Original · priorityReviewAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industryGMP disciplineFDA drug shortagesFDA 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 →