Last Updated: November 5, 2026

Details for New Drug Application (NDA): 214289

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NDA 214289 describes MYCOPHENOLATE SODIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Fosun Wanbang, Rk Pharma, Teva Pharms Usa, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from sixteen suppliers. Additional details are available on the MYCOPHENOLATE SODIUM profile page.

The generic ingredient in MYCOPHENOLATE SODIUM is mycophenolate sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.

Summary for 214289

Tradename:	MYCOPHENOLATE SODIUM
Applicant:	Twi Pharms
Ingredient:	mycophenolate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 180MG BASE
Approval Date:	Nov 3, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 360MG BASE
Approval Date:	Nov 3, 2021	TE:		RLD:	No

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