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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050320

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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EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: Yes
Reference Standard: No
TE Code: 
Application Number: N050320
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status:  Discontinued
Patent and Exclusivity Information
UNIPEN (NAFCILLIN SODIUM)
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: Yes
Reference Standard: No
TE Code: 
Application Number: N050320
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status:  Discontinued
Patent and Exclusivity Information
UNIPEN (NAFCILLIN SODIUM)
EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050320
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status:  Discontinued
Patent and Exclusivity Information
UNIPEN (NAFCILLIN SODIUM)
EQ 10GM 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 10GM BASE/VIAL **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: N050320
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status:  Discontinued
Patent and Exclusivity Information
UNIPEN (NAFCILLIN SODIUM)
EQ 20GM 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 20GM BASE/VIAL **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: N050320
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status:  Discontinued
Patent and Exclusivity Information
UNIPEN IN PLASTIC CONTAINER (NAFCILLIN SODIUM)
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 IN PLASTIC CONTAINER
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: Yes
Reference Standard: No
TE Code: 
Application Number: N050320
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status:  Discontinued
Patent and Exclusivity Information
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