Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214350
Company: LUPIN

Products on ANDA 214350

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DASATINIB	DASATINIB	20MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DASATINIB	DASATINIB	50MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DASATINIB	DASATINIB	70MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DASATINIB	DASATINIB	80MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DASATINIB	DASATINIB	100MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DASATINIB	DASATINIB	140MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214350

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2022	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.