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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220437
Company: SANDOZ INC

Products on ANDA 220437

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIVOZANIB	TIVOZANIB	.89MG	CAPSULE	None (Tentative Approval)	None	No	No
TIVOZANIB	TIVOZANIB	1.34MG	CAPSULE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220437

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2026	ORIG-1	Tentative Approval	Labeling	UNKNOWN		Label is not available on this site.

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