Product Details for NDA 005897
FOLVITE (FOLIC ACID)
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FOLIC ACID
Proprietary Name: FOLVITE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N005897
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
FOLVITE (FOLIC ACID)
Proprietary Name: FOLVITE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N005897
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FOLIC ACID
Proprietary Name: FOLVITE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N005897
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FOLVITE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N005897
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information