Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 060657

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PFIZERPEN (PENICILLIN G POTASSIUM)
5,000,000 UNITS/VIAL
Marketing Status: Prescription

Active Ingredient: PENICILLIN G POTASSIUM
Proprietary Name: PFIZERPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000,000 UNITS/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A060657
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER LABORATORIES DIV PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PFIZERPEN (PENICILLIN G POTASSIUM)
20,000,000 UNITS/VIAL
Marketing Status: Prescription

Active Ingredient: PENICILLIN G POTASSIUM
Proprietary Name: PFIZERPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20,000,000 UNITS/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A060657
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER LABORATORIES DIV PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PFIZERPEN (PENICILLIN G POTASSIUM)
1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PENICILLIN G POTASSIUM
Proprietary Name: PFIZERPEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A060657
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER LABORATORIES DIV PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information