Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203719

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PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Proprietary Name: PIPERACILLIN AND TAZOBACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203719
Product Number: 001
Approval Date: May 18, 2018
Applicant Holder Full Name: FRESENIUS KABI ANTI INFECTIVES SRL
Marketing Status:  Prescription
Patent and Exclusivity Information

PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Proprietary Name: PIPERACILLIN AND TAZOBACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203719
Product Number: 002
Approval Date: May 18, 2018
Applicant Holder Full Name: FRESENIUS KABI ANTI INFECTIVES SRL
Marketing Status:  Prescription
Patent and Exclusivity Information

PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Proprietary Name: PIPERACILLIN AND TAZOBACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203719
Product Number: 003
Approval Date: May 18, 2018
Applicant Holder Full Name: FRESENIUS KABI ANTI INFECTIVES SRL
Marketing Status:  Prescription
Patent and Exclusivity Information