Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050309

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POLYCILLIN-N (AMPICILLIN SODIUM)
EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: AMPICILLIN SODIUM
Proprietary Name: POLYCILLIN-N
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050309
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

POLYCILLIN-N (AMPICILLIN SODIUM)
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: AMPICILLIN SODIUM
Proprietary Name: POLYCILLIN-N
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050309
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

POLYCILLIN-N (AMPICILLIN 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EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: AMPICILLIN SODIUM
Proprietary Name: POLYCILLIN-N
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Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050309
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

POLYCILLIN-N (AMPICILLIN 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: AMPICILLIN SODIUM
Proprietary Name: POLYCILLIN-N
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: N050309
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

POLYCILLIN-N (AMPICILLIN 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: AMPICILLIN SODIUM
Proprietary Name: POLYCILLIN-N
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: N050309
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status:  Discontinued
Patent and Exclusivity Information