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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219530
Company: MACLEODS PHARMS LTD

Products on ANDA 219530

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Therapeutic Equivalents for ANDA 219530

TOFACITINIB CITRATE

TABLET;ORAL; EQ 5MG 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 5MG BASE	TABLET;ORAL	Prescription	No	AB	218096	APOTEX
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	215356	AUROBINDO PHARMA LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	209633	BRECKENRIDGE
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	219530	MACLEODS PHARMS LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	209738	MICRO LABS
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	217299	MSN
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	220137	SOMERSET THERAPS LLC
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	219395	SPECGX LLC
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	209829	ZYDUS PHARMS
XELJANZ	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	203214	PF PRISM CV

TABLET;ORAL; EQ 10MG 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 10MG BASE	TABLET;ORAL	Prescription	No	AB	212943	AJANTA PHARMA LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	218096	APOTEX
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	215356	AUROBINDO PHARMA LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	209633	BRECKENRIDGE
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	219530	MACLEODS PHARMS LTD
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	209738	MICRO LABS
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	217299	MSN
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	220137	SOMERSET THERAPS LLC
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	219395	SPECGX LLC
XELJANZ	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	203214	PF PRISM CV

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