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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219236
Company: SYNTHON BV

Products on ANDA 219236

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OZANIMOD	OZANIMOD	0.92MG	CAPSULE	None (Tentative Approval)	None	No	No
OZANIMOD	OZANIMOD	0.46MG	CAPSULE	None (Tentative Approval)	None	No	No
OZANIMOD	OZANIMOD	0.23MG	CAPSULE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219236

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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