← FDA DRUG APPROVALS

FDA NDA · NDA214218

PEMETREXED

Sponsor: HOSPIRA

APPLICATION
NDA214218
TYPE
NDA
ORIGINAL APPROVAL
2022-06-22
LATEST ACTION
2022-06-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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
PEMETREXED DISODIUM · ReferencePrescription
PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-06-22Type 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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