Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050138

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BICILLIN C-R (PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE)
300,000 UNITS/ML;300,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Proprietary Name: BICILLIN C-R
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 300,000 UNITS/ML;300,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050138
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KING PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BICILLIN C-R 900/300 (PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE)
900,000 UNITS/2ML;300,000 UNITS/2ML
Marketing Status: Prescription

Active Ingredient: PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Proprietary Name: BICILLIN C-R 900/300
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 900,000 UNITS/2ML;300,000 UNITS/2ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050138
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KING PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BICILLIN C-R (PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE)
150,000 UNITS/ML;150,000 UNITS/ML
Marketing Status: Discontinued

Active Ingredient: PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Proprietary Name: BICILLIN C-R
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150,000 UNITS/ML;150,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050138
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KING PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information