Details for New Drug Application (NDA): 214376

NDA 214376 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 eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.

Summary for 214376

Tradename:	MYCOPHENOLATE SODIUM
Applicant:	Yichang Humanwell
Ingredient:	mycophenolate sodium
Patents:	0

Pharmacology for NDA: 214376

Suppliers and Packaging for NDA: 214376

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE SODIUM	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	214376	ANDA	Slate Run Pharmaceuticals, LLC	70436-172	70436-172-23	120 TABLET, DELAYED RELEASE in 1 BOTTLE (70436-172-23)
MYCOPHENOLATE SODIUM	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	214376	ANDA	Slate Run Pharmaceuticals, LLC	70436-173	70436-173-23	120 TABLET, DELAYED RELEASE in 1 BOTTLE (70436-173-23)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 180MG BASE
Approval Date:	Feb 10, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 360MG BASE
Approval Date:	Feb 10, 2021	TE:	AB	RLD:	No

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