Last Updated: September 24, 2026

Details for New Drug Application (NDA): 050558


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NDA 050558 describes ZINACEF, which is a drug marketed by Pai Holdings Pharm and is included in two NDAs. Additional details are available on the ZINACEF profile page.

The generic ingredient in ZINACEF is cefuroxime sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 050558
Tradename:ZINACEF
Applicant:Pai Holdings Pharm
Ingredient:cefuroxime sodium
Patents:0

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 19, 1983TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 19, 1983TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 23, 1986TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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