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US Department of Justice
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AstraZeneca
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Generated: August 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065363

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NDA 065363 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Apollo Pharms Inc, Aurobindo Pharma Ltd, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Qilu Tianhe, Sandoz, Sandoz Inc, and Wockhardt Bio Ag, and is included in seventeen NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 065363
Tradename:PIPERACILLIN AND TAZOBACTAM
Applicant:Sandoz
Ingredient:piperacillin sodium; tazobactam sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065363
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065363 ANDA Hospira, Inc 0409-3374 N 0409-3374-02
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065363 ANDA Hospira, Inc 0409-3378 N 0409-3378-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Oct 21, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date:Oct 21, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Oct 21, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Medtronic
Moodys
Colorcon
Fish and Richardson
Cantor Fitzgerald
Julphar
Healthtrust
US Department of Justice

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