Product Details for ANDA 065114
PIPERACILLIN (PIPERACILLIN SODIUM)
EQ 2GM BASE/VIAL
Marketing Status: Prescription
EQ 3GM BASE/VIAL
Marketing Status: Prescription
EQ 4GM BASE/VIAL
Marketing Status: Prescription
EQ 2GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PIPERACILLIN SODIUM
Proprietary Name: PIPERACILLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A065114
Product Number: 001
Approval Date: Nov 14, 2003
Applicant Holder Full Name: ISTITUTO BIOCHIMICO ITALIANO SPA
Marketing Status: Prescription
Patent and Exclusivity Information
PIPERACILLIN (PIPERACILLIN SODIUM)
Proprietary Name: PIPERACILLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A065114
Product Number: 001
Approval Date: Nov 14, 2003
Applicant Holder Full Name: ISTITUTO BIOCHIMICO ITALIANO SPA
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 3GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PIPERACILLIN SODIUM
Proprietary Name: PIPERACILLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 3GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A065114
Product Number: 002
Approval Date: Nov 14, 2003
Applicant Holder Full Name: ISTITUTO BIOCHIMICO ITALIANO SPA
Marketing Status: Prescription
Patent and Exclusivity Information
PIPERACILLIN (PIPERACILLIN SODIUM)
Proprietary Name: PIPERACILLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 3GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A065114
Product Number: 002
Approval Date: Nov 14, 2003
Applicant Holder Full Name: ISTITUTO BIOCHIMICO ITALIANO SPA
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 4GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PIPERACILLIN SODIUM
Proprietary Name: PIPERACILLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A065114
Product Number: 003
Approval Date: Nov 14, 2003
Applicant Holder Full Name: ISTITUTO BIOCHIMICO ITALIANO SPA
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PIPERACILLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A065114
Product Number: 003
Approval Date: Nov 14, 2003
Applicant Holder Full Name: ISTITUTO BIOCHIMICO ITALIANO SPA
Marketing Status: Prescription
Patent and Exclusivity Information