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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065362

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NDA 065362 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Apollo Pharms Inc, Aurobindo Pharma Ltd, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Sandoz, Wockhardt Bio Ag, and Sandoz Inc, and is included in thirteen NDAs. It is available from twelve 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 fourteen 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 065362

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065362

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065362

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065362 ANDA Hospira, Inc 0409-3383 0409-3383-02 10 VIAL, SINGLE-USE in 1 CARTON (0409-3383-02) > 10 mL in 1 VIAL, SINGLE-USE
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065362 ANDA Hospira, Inc 0409-3385 0409-3385-13 10 VIAL, SINGLE-USE in 1 CARTON (0409-3385-13) > 15 mL in 1 VIAL, SINGLE-USE

Summary 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

Summary 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

Summary 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 leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Chubb
Express Scripts
US Department of Justice
Citi
Boehringer Ingelheim
US Army
Cipla
Cantor Fitzgerald

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