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FDA ANDA · ANDA090384

PEMETREXED

pemetrexed disodium

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA090384
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-25
LATEST ACTION
2023-09-25
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 750MG BASE/VIAL · POWDER · INTRAVENOUS
PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS
PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS
PEMETREXED DISODIUMPrescription
PEMETREXED DISODIUM EQ 500MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2023-09-25Labeling · Supplement 1 · standardAP
2022-05-25OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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