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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. 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. Twenty suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for NDA: 020363

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Apr 26, 1996TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Jun 29, 1994TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength125MG
Approval Date:Dec 11, 1995TE:RLD:Yes

Expired Orange Book Patents for NDA: 020363

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-002Jun 29, 19945,840,763*PED► Subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-003Dec 11, 19955,246,937*PED► Subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-001Apr 26, 19966,124,304*PED► Subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-002Jun 29, 19945,866,581*PED► Subscribe
Novartis
FAMVIR
famciclovir
TABLET;ORAL020363-001Apr 26, 19965,246,937*PED► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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