APPLICATION
ANDA208927
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)
Products
PEMETREXEDNone (Tentative Approval)
PEMETREXED 100MG · INJECTABLE · INJECTION
PEMETREXEDNone (Tentative Approval)
PEMETREXED 500MG · INJECTABLE · INJECTION
Approval history
2018-05-04UNKNOWN · Original · standardTA
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.