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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219442
Company: BIOCON PHARMA

Products on ANDA 219442

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	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2025	ORIG-2	Tentative Approval		STANDARD		Label is not available on this site.
11/17/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219442

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	219442	BIOCON PHARMA
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216001	SINOTHERAPEUTICS INC
XELJANZ XR	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	208246	PFIZER

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