Last Updated: November 13, 2026

Details for New Drug Application (NDA): 217449

NDA 217449 describes BALOXAVIR MARBOXIL, which is a drug marketed by Norwich and is included in one NDA. Additional details are available on the BALOXAVIR MARBOXIL profile page.

The generic ingredient in BALOXAVIR MARBOXIL is baloxavir marboxil. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.

Summary for 217449

Tradename:	BALOXAVIR MARBOXIL
Applicant:	Norwich
Ingredient:	baloxavir marboxil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jun 17, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jun 17, 2026	TE:	AB	RLD:	No

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