APPLICATION
ANDA203485
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-25
LATEST ACTION
2025-08-06
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS
PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS
PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 500MG BASE/VIAL · POWDER · INTRAVENOUS
Approval history
2025-08-06Labeling · Supplement 4 · standardAP
2023-08-29Labeling · Supplement 2 · standardAP
2022-05-25UNKNOWN · OriginalAP
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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