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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 two suppliers. 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 NDA: 050679

Tradename:
MAXIPIME
Applicant:
Hospira Inc
Ingredient:
cefepime hydrochloride
Patents:0
Therapeutic Class:Antibacterials

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 0409-0217-01 25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0217-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0217-11)
MAXIPIME
cefepime hydrochloride
INJECTABLE;INJECTION 050679 NDA Hospira, Inc. 0409-0218 0409-0218-01 25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON (0409-0218-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-0218-11)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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