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FDA ANDA · ANDA208003

FINGOLIMOD

Sponsor: PRINSTON INC

APPLICATION
ANDA208003
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-07
LATEST ACTION
2024-12-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FINGOLIMOD HYDROCHLORIDEPrescription
FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL

Approval history

2024-12-17Labeling · Supplement 2 · standardAP
2022-09-07UNKNOWN · Original · standardLetterAP
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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