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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090498

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NDA 090498 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 fifteen 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 090498
Tradename:PIPERACILLIN AND TAZOBACTAM
Applicant:Istituto Bio Ita Spa
Ingredient:piperacillin sodium; tazobactam sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090498
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 090498
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 090498 ANDA WG Critical Care, LLC 44567-804 N 44567-804-01
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 090498 ANDA Fresenius Kabi USA, LLC 63323-304 E 63323-304-74

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:May 31, 2011TE:APRLD:No

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