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FDA NDA · NDA214408

PEMETREXED DISODIUM

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA214408
TYPE
NDA
ORIGINAL APPROVAL
2022-07-19
LATEST ACTION
2025-01-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PEMETREXED DISODIUM · ReferenceDiscontinued
PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS
PEMETREXED DISODIUM · ReferenceDiscontinued
PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS
PEMETREXED DISODIUM · ReferenceDiscontinued
PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS
PEMETREXED DISODIUM · ReferenceDiscontinued
PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-01-16Labeling · Supplement 5 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 3 · standard — Label ↗AP
2022-07-19Type 3 - New Dosage Form · 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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