APPLICATION
NDA021677
TYPE
NDA
ORIGINAL APPROVAL
2004-08-19
LATEST ACTION
2004-08-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ALIMTAPrescription
PEMETREXED 500MG · INJECTABLE · INJECTION
Approval history
2004-08-19Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Label ↗AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.