Details for New Drug Application (NDA): 203720

NDA 203720 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.

Summary for 203720

Tradename:	PIPERACILLIN AND TAZOBACTAM
Applicant:	Fresenius Kabi
Ingredient:	piperacillin sodium; tazobactam sodium
Patents:	0

Pharmacology for NDA: 203720

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 203720

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	203720	ANDA	Fresenius Kabi USA, LLC	65219-256	65219-256-28	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65219-256-28) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE
PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	203720	ANDA	Fresenius Kabi USA, LLC	65219-256	65219-256-00	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65219-256-00) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:	May 11, 2018	TE:	AP	RLD:	No

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