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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. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. 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. Nineteen suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for NDA: 020363

Tradename:
FAMVIR
Applicant:
Novartis
Ingredient:
famciclovir
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020363

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 020363

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMVIR
famciclovir
TABLET;ORAL 020363 NDA Novartis Pharmaceuticals Corporation 0078-0366 0078-0366-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0366-15)
FAMVIR
famciclovir
TABLET;ORAL 020363 NDA Novartis Pharmaceuticals Corporation 0078-0367 0078-0367-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0367-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 26, 1996TE:ABRLD:No
Patent:5,840,763*PEDPatent Expiration:Mar 1, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:5,916,893*PEDPatent Expiration:Mar 1, 2016Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 29, 1994TE:ABRLD:Yes
Patent:5,840,763*PEDPatent Expiration:Mar 1, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020363

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-001Apr 26, 19965,866,581*PED► subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-003Dec 11, 19955,246,937*PED► subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-001Apr 26, 19965,916,893*PED► subscribe
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