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	22MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	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
09/30/2025	ORIG-2	Tentative Approval		STANDARD		Label is not available on this site.
09/30/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216001

TOFACITINIB

There are no Therapeutic Equivalents.

TOFACITINIB CITRATE

TABLET, EXTENDED RELEASE;ORAL; EQ 11MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	218462	AUROBINDO PHARMA LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	219442	BIOCON PHARMA
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216001	SINOTHERAPEUTICS INC
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214264	ZYDUS PHARMS
XELJANZ XR	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	208246	PFIZER