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FDA NDA · NDA214657

PEMETREXED

pemetrexed disodium

Sponsor: SANDOZ

APPLICATION
NDA214657
TYPE
NDA
ORIGINAL APPROVAL
2022-05-26
LATEST ACTION
2025-12-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PEMETREXED DISODIUM · ReferencePrescription
PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS
PEMETREXED DISODIUM · ReferencePrescription
PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS
PEMETREXED DISODIUM · ReferencePrescription
PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-12-15Labeling · Supplement 6 · standard — Label ↗AP
2023-04-21Labeling · Supplement 3 · standard — Letter ↗AP
2022-05-26Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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