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Details for New Drug Application (NDA): 090498

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NDA 090498 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Istituto Bio Ita Spa, Hospira Inc, Sandoz Inc, Mylan Labs Ltd, Sandoz, and Aurobindo Pharma Ltd, and is included in nine NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for NDA: 090498

Pharmacology for NDA: 090498

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 sodium; tazobactam sodium
INJECTABLE;INJECTION 090498 ANDA WG Critical Care, LLC 44567-804 44567-804-01 1 BOTTLE in 1 BOX (44567-804-01) > 180 mL in 1 BOTTLE
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 090498 ANDA Fresenius Kabi USA, LLC 63323-304 63323-304-94 1 BOTTLE in 1 CARTON (63323-304-94) > 180 mL in 1 BOTTLE

Summary for product number 001

Approval Date:May 31, 2011TE:APRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.