Details for New Drug Application (NDA): 050750

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NDA 050750 describes ZOSYN IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from two suppliers. Additional details are available on the ZOSYN IN PLASTIC CONTAINER profile page.

The generic ingredient in ZOSYN IN PLASTIC CONTAINER 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 050750

Tradename:	ZOSYN IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare Corp
Ingredient:	piperacillin sodium; tazobactam sodium
Patents:	0

Pharmacology for NDA: 050750

Mechanism of Action	beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0206-8860	0206-8860-02	24 BAG in 1 BOX (0206-8860-02) / 50 mL in 1 BAG (0206-8860-01)
ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0206-8861	0206-8861-02	24 BAG in 1 BOX (0206-8861-02) / 50 mL in 1 BAG (0206-8861-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 40MG BASE/ML;EQ 5MG BASE/ML
Approval Date:	Feb 24, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
Approval Date:	Feb 24, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
Approval Date:	Feb 24, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 050750

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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