Product Details for ANDA 062717
UNIPEN (NAFCILLIN SODIUM)
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NAFCILLIN SODIUM
Proprietary Name: UNIPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A062717
Product Number: 001
Approval Date: Dec 16, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
UNIPEN (NAFCILLIN SODIUM)
Proprietary Name: UNIPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A062717
Product Number: 001
Approval Date: Dec 16, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NAFCILLIN SODIUM
Proprietary Name: UNIPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A062717
Product Number: 002
Approval Date: Dec 16, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
UNIPEN (NAFCILLIN SODIUM)
Proprietary Name: UNIPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **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: A062717
Product Number: 002
Approval Date: Dec 16, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NAFCILLIN SODIUM
Proprietary Name: UNIPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **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: A062717
Product Number: 004
Approval Date: Dec 16, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: UNIPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **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: A062717
Product Number: 004
Approval Date: Dec 16, 1986
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information