Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203557

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PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 12GM BASE/VIAL;EQ 1.5GM 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 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A203557
Product Number: 001
Approval Date: Oct 29, 2014
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 36GM BASE/VIAL;EQ 4.5GM 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 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203557
Product Number: 002
Approval Date: Jul 8, 2021
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information