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Details for New Drug Application (NDA): 050750

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NDA 050750 describes ZOSYN IN PLASTIC CONTAINER, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. 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 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: 050750

Tradename:
ZOSYN IN PLASTIC CONTAINER
Applicant:
Wyeth Pharms Inc
Ingredient:
piperacillin sodium; tazobactam sodium
Patents:4
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050750

Ingredient-typePenicillins
Mechanism of Actionbeta 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 Inc., a subsidiary of Pfizer Inc. 0206-2409 0206-2409-02 24 BAG in 1 BOX (0206-2409-02) > 50 mL in 1 BAG (0206-2409-01)
ZOSYN IN PLASTIC CONTAINER
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION 050750 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0206-2411 0206-2411-02 24 BAG in 1 BOX (0206-2411-02) > 50 mL in 1 BAG (0206-2411-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML;EQ 5MG BASE/ML
Approval Date:Feb 24, 1998TE:RLD:Yes
Patent:6,207,661Patent Expiration:Feb 22, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,915,229Patent Expiration:Apr 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:6,900,184Patent Expiration:Apr 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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