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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210703
Company: SANDOZ INC

Products on ANDA 210703

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AFATINIB	AFATINIB	50MG	TABLET	None (Tentative Approval)	None	No	No
AFATINIB	AFATINIB	30MG	TABLET	None (Tentative Approval)	None	No	No
AFATINIB	AFATINIB	20MG	TABLET	None (Tentative Approval)	None	No	No
AFATINIB	AFATINIB	40MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210703

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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