← FDA DRUG APPROVALS

FDA ANDA · ANDA206167

PRALATREXATE

Sponsor: TEVA PHARMS USA INC

APPLICATION
ANDA206167
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)

Products

PRALATREXATENone (Tentative Approval)
PRALATREXATE 40MG/2ML · INJECTABLE · INJECTION
PRALATREXATENone (Tentative Approval)
PRALATREXATE 20MG/1ML · INJECTABLE · INJECTION

Approval history

2016-01-21UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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 →