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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214264
Company: ZYDUS PHARMS

Products on ANDA 214264

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	EQ 22MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214264Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214264

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

TABLET, EXTENDED RELEASE;ORAL; EQ 22MG 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 22MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214264	ZYDUS PHARMS
XELJANZ XR	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	208246	PFIZER

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