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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090128

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NDA 090128 describes FAMCICLOVIR, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Teva Pharms, and West-ward Pharms Int, and is included in eight NDAs. It is available from nineteen suppliers. Additional details are available on the FAMCICLOVIR profile page.

The generic ingredient in FAMCICLOVIR 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 090128
Tradename:FAMCICLOVIR
Applicant:West-ward Pharms Int
Ingredient:famciclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 090128
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 090128
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMCICLOVIR famciclovir TABLET;ORAL 090128 ANDA West-Ward Pharmaceuticals Corp. 0054-0196 N 0054-0196-13
FAMCICLOVIR famciclovir TABLET;ORAL 090128 ANDA West-Ward Pharmaceuticals Corp. 0054-0197 N 0054-0197-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Mar 21, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 21, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 21, 2011TE:ABRLD:No

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