Last Updated: June 17, 2026

Details for New Drug Application (NDA): 218668

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NDA 218668 describes TOFACITINIB CITRATE, which is a drug marketed by Hikma, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Sinotherapeutics Inc, Zydus Pharms, and Micro Labs, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the TOFACITINIB CITRATE profile page.

The generic ingredient in TOFACITINIB CITRATE is tofacitinib citrate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

Summary for 218668

Tradename:	TOFACITINIB CITRATE
Applicant:	Dexcel
Ingredient:	tofacitinib citrate
Patents:	0

Pharmacology for NDA: 218668

Mechanism of Action	Janus Kinase Inhibitors

Suppliers and Packaging for NDA: 218668

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOFACITINIB CITRATE	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	218668	ANDA	Edenbridge Pharmaceuticals LLC.	42799-970	42799-970-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42799-970-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 11MG BASE
Approval Date:	Dec 16, 2024	TE:	AB	RLD:	No

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