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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050791

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NDA 050791 describes MYFORTIC, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the MYFORTIC profile page.

The generic ingredient in MYFORTIC is mycophenolate sodium. There are thirty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.

Summary for 050791

Tradename:	MYFORTIC
Applicant:	Novartis
Ingredient:	mycophenolate sodium
Patents:	0

Pharmacology for NDA: 050791

Suppliers and Packaging for NDA: 050791

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791	NDA	Novartis Pharmaceuticals Corporation	0078-0385	0078-0385-66	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)
MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791	NDA	Novartis Pharmaceuticals Corporation	0078-0386	0078-0386-66	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 180MG BASE
Approval Date:	Feb 27, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 360MG BASE
Approval Date:	Feb 27, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050791

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	6,025,391	⤷ Get Started Free
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,306,900	⤷ Get Started Free
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,025,391	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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