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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 020363

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NDA 020363 describes FAMVIR, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the FAMVIR profile page.

The generic ingredient in FAMVIR is famciclovir. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for 020363

Tradename:	FAMVIR
Applicant:	Novartis
Ingredient:	famciclovir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 26, 1996	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 29, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 11, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020363

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996	5,916,893*PED	⤷ Start Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	5,916,893*PED	⤷ Start Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	5,246,937*PED	⤷ Start Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	6,124,304*PED	⤷ Start Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	5,246,937*PED	⤷ Start Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	5,866,581*PED	⤷ Start Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996	5,866,581*PED	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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