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FDA NDA · NDA209472

PEMFEXY

pemetrexed

Sponsor: EAGLE PHARMS

APPLICATION
NDA209472
TYPE
NDA
ORIGINAL APPROVAL
2020-02-08
LATEST ACTION
2022-12-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PEMFEXY · ReferencePrescription
PEMETREXED 500MG/20ML (25MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-12-14Efficacy · Supplement 5 · standard — Letter ↗AP
2020-06-17Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2020-02-08Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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.

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