Details for New Drug Application (NDA): 207146

NDA 207146 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 fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for 207146

Tradename:	PIPERACILLIN AND TAZOBACTAM
Applicant:	Wockhardt Bio Ag
Ingredient:	piperacillin sodium; tazobactam sodium
Patents:	0

Pharmacology for NDA: 207146

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 207146

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	207146	ANDA	Wockhardt USA LLC.	64679-679	64679-679-01	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (64679-679-01) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE (64679-679-02)

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:	Mar 17, 2017	TE:	AP	RLD:	No

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