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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219705
Company: SANDOZ INC

Products on ANDA 219705

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AXITINIB	AXITINIB	5MG	TABLET	None (Tentative Approval)	None	No	No
AXITINIB	AXITINIB	1MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219705

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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