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Generated: April 26, 2017

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Details for New Drug Application (NDA): 065446

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NDA 065446 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Istituto Bio Ita Spa, Hospira Inc, Wockhardt Bio Ag, Apollo Pharms Inc, Sandoz Inc, Mylan Labs Ltd, Sandoz, and Aurobindo Pharma Ltd, 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 NDA: 065446

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

Pharmacology for NDA: 065446

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065446

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 065446 ANDA Apotex Corporation 60505-0773 60505-0773-0 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-0773-0) > 152 mL in 1 VIAL, PHARMACY BULK PACKAGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:Sep 15, 2009TE:APRLD:No


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