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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216001
Company: SINOTHERAPEUTICS INC

Products on ANDA 216001

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOFACITINIB	TOFACITINIB	11MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
TOFACITINIB	TOFACITINIB	22MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216001

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2023	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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