Product Details for ANDA 065458
PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM; TAZOBACTAM SODIUM)
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Marketing Status: Prescription
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Marketing Status: Prescription
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Marketing Status: Prescription
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: A065458
Product Number: 001
Approval Date: Aug 15, 2014
Applicant Holder Full Name: STERISCIENCE SPECIALITIES PTE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PIPERACILLIN AND TAZOBACTAM (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: A065458
Product Number: 001
Approval Date: Aug 15, 2014
Applicant Holder Full Name: STERISCIENCE SPECIALITIES PTE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A065458
Product Number: 002
Approval Date: Aug 15, 2014
Applicant Holder Full Name: STERISCIENCE SPECIALITIES PTE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PIPERACILLIN AND TAZOBACTAM (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: A065458
Product Number: 002
Approval Date: Aug 15, 2014
Applicant Holder Full Name: STERISCIENCE SPECIALITIES PTE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A065458
Product Number: 003
Approval Date: Aug 15, 2014
Applicant Holder Full Name: STERISCIENCE SPECIALITIES PTE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A065458
Product Number: 003
Approval Date: Aug 15, 2014
Applicant Holder Full Name: STERISCIENCE SPECIALITIES PTE LTD
Marketing Status: Prescription
Patent and Exclusivity Information