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Details for New Drug Application (NDA): 065114

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NDA 065114 describes PIPERACILLIN, 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 eleven NDAs. Additional details are available on the PIPERACILLIN profile page.

The generic ingredient in PIPERACILLIN 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: 065114

Tradename:
PIPERACILLIN
Applicant:
Istituto Bio Ita Spa
Ingredient:
piperacillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Nov 14, 2003TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL
Approval Date:Nov 14, 2003TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL
Approval Date:Nov 14, 2003TE:RLD:Yes


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