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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 050558


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

The generic ingredient in ZINACEF is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 050558
Tradename:ZINACEF
Applicant:Teligent
Ingredient:cefuroxime sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 750MG BASE/VIAL
Approval Date:Oct 19, 1983TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5GM BASE/VIAL
Approval Date:Oct 19, 1983TE:APRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 7.5GM BASE/VIAL
Approval Date:Oct 23, 1986TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Dow
Medtronic
Mallinckrodt
AstraZeneca

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