Product Details for NDA 020363
FAMVIR (FAMCICLOVIR)
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMCICLOVIR
Proprietary Name: FAMVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020363
Product Number: 003
Approval Date: Dec 11, 1995
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
FAMVIR (FAMCICLOVIR)
Proprietary Name: FAMVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020363
Product Number: 003
Approval Date: Dec 11, 1995
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMCICLOVIR
Proprietary Name: FAMVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020363
Product Number: 001
Approval Date: Apr 26, 1996
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
FAMVIR (FAMCICLOVIR)
Proprietary Name: FAMVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020363
Product Number: 001
Approval Date: Apr 26, 1996
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMCICLOVIR
Proprietary Name: FAMVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020363
Product Number: 002
Approval Date: Jun 29, 1994
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FAMVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020363
Product Number: 002
Approval Date: Jun 29, 1994
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information