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FDA ANDA · ANDA219236

OZANIMOD

Sponsor: SYNTHON BV

APPLICATION
ANDA219236
TYPE
ANDA
DOSAGE FORM
CAPSULE
MARKETING STATUS
None (Tentative Approval)

Products

OZANIMODNone (Tentative Approval)
OZANIMOD 0.23MG · CAPSULE
OZANIMODNone (Tentative Approval)
OZANIMOD 0.46MG · CAPSULE

Approval history

2025-07-22UNKNOWN · Original · standardTA
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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