Details for New Drug Application (NDA): 090498

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NDA 090498 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience Speclts, and Wockhardt Bio Ag, and is included in twenty-two NDAs. It is available from fifteen 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 sixteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Tradename:	PIPERACILLIN AND TAZOBACTAM
Applicant:	Istituto Bio Ita Spa
Ingredient:	piperacillin sodium; tazobactam sodium
Patents:	0

Mechanism of Action	beta Lactamase Inhibitors

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	44567-804-01	1 BOTTLE in 1 BOX (44567-804-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	090498	ANDA	Fresenius Kabi USA, LLC	63323-304	63323-304-78	1 BOTTLE in 1 CARTON (63323-304-78) / 180 mL in 1 BOTTLE

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:	May 31, 2011	TE:	AP	RLD:	No

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