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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 065386


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NDA 065386 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Astral, Aurobindo Pharma Ltd, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Provepharm Sas, Qilu, Sagent Pharms Inc, Sandoz, Sandoz Inc, and Wockhardt Bio Ag, and is included in twenty NDAs. It is available from fourteen suppliers. Additional details are available on the PIPERACILLIN AND TAZOBACTAM profile page.

The generic ingredient in PIPERACILLIN AND TAZOBACTAM is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 065386

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Sep 15, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date:Sep 15, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Sep 15, 2009TE:RLD:No

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