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Healthtrust
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US Department of Justice
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050679

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NDA 050679 describes MAXIPIME, which is a drug marketed by Hospira Inc and is included in one NDA. It is available from one supplier. Additional details are available on the MAXIPIME profile page.

The generic ingredient in MAXIPIME is cefepime hydrochloride. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
Summary for 050679
Tradename:MAXIPIME
Applicant:Hospira Inc
Ingredient:cefepime hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050679
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 050679
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXIPIME cefepime hydrochloride INJECTABLE;INJECTION 050679 NDA Hospira, Inc. 0409-0217 N 0409-0217-01
MAXIPIME cefepime hydrochloride INJECTABLE;INJECTION 050679 NDA Hospira, Inc. 0409-0218 N 0409-0218-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 18, 1996TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jan 18, 1996TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jan 18, 1996TE:APRLD:Yes

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