Product Details for NDA 050750
ZOSYN IN PLASTIC CONTAINER (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 40MG BASE/ML;EQ 5MG BASE/ML
Marketing Status: Prescription
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
Marketing Status: Prescription
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
Marketing Status: Prescription
EQ 40MG BASE/ML;EQ 5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Proprietary Name: ZOSYN IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 40MG BASE/ML;EQ 5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N050750
Product Number: 001
Approval Date: Feb 24, 1998
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
ZOSYN IN PLASTIC CONTAINER (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
Proprietary Name: ZOSYN IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 40MG BASE/ML;EQ 5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N050750
Product Number: 001
Approval Date: Feb 24, 1998
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Proprietary Name: ZOSYN IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N050750
Product Number: 002
Approval Date: Feb 24, 1998
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
ZOSYN IN PLASTIC CONTAINER (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
Proprietary Name: ZOSYN IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N050750
Product Number: 002
Approval Date: Feb 24, 1998
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
Marketing Status: Prescription
Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Proprietary Name: ZOSYN IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N050750
Product Number: 003
Approval Date: Feb 24, 1998
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ZOSYN IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N050750
Product Number: 003
Approval Date: Feb 24, 1998
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information