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FDA NDA · NDA208419

PEMETREXED

Sponsor: ACTAVIS

APPLICATION
NDA208419
TYPE
NDA
ORIGINAL APPROVAL
2020-08-21
LATEST ACTION
2022-11-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2022-11-22Efficacy · Supplement 3 · standard — Label ↗AP
2022-11-22Efficacy · Supplement 4 · standard — Label ↗AP
2022-11-22Efficacy · Supplement 2 · standard — Label ↗AP
2020-08-21Type 2 - New Active Ingredient · 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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