Product Details for NDA 020089
ZOVIRAX (ACYCLOVIR)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACYCLOVIR
Proprietary Name: ZOVIRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020089
Product Number: 001
Approval Date: Apr 30, 1991
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOVIRAX (ACYCLOVIR)
Proprietary Name: ZOVIRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020089
Product Number: 001
Approval Date: Apr 30, 1991
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACYCLOVIR
Proprietary Name: ZOVIRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020089
Product Number: 002
Approval Date: Apr 30, 1991
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZOVIRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020089
Product Number: 002
Approval Date: Apr 30, 1991
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information