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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218668
Company: DEXCEL

Products on ANDA 218668

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218668

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2024	ORIG-2	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218668Orig1s000ltr,218668Orig1s000TAltr.pdf
12/16/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218668Orig1s000ltr,218668Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 218668

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	219542	AJANTA PHARMA LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	220458	APOTEX
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	218668	DEXCEL
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	219830	ORIENT 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

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