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Generated: September 26, 2018

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Details for New Drug Application (NDA): 050684

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NDA 050684 describes ZOSYN, which is a drug marketed by Wyeth Pharms and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZOSYN profile page.

The generic ingredient in ZOSYN is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 050684
Tradename:ZOSYN
Applicant:Wyeth Pharms
Ingredient:piperacillin sodium; tazobactam sodium
Patents:3
Pharmacology for NDA: 050684
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0206-8852 0206-8852-16 10 VIAL, SINGLE-USE in 1 CARTON (0206-8852-16) > 10 mL in 1 VIAL, SINGLE-USE (0206-8852-08)
ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0206-8854 0206-8854-16 10 VIAL, SINGLE-USE in 1 CARTON (0206-8854-16) > 15 mL in 1 VIAL, SINGLE-USE (0206-8854-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Oct 22, 1993TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:➤ Try a Free TrialPatent Expiration:Apr 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS

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