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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065369

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NDA 065369 describes CEFEPIME HYDROCHLORIDE, which is a drug marketed by Acs Dobfar, Hospira Inc, Qilu Pharm Co Ltd, Sagent Pharms, and Sandoz, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the CEFEPIME HYDROCHLORIDE profile page.

The generic ingredient in CEFEPIME HYDROCHLORIDE 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 065369

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065369

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065369

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFEPIME HYDROCHLORIDE cefepime hydrochloride INJECTABLE;INJECTION 065369 ANDA Apotex Corporation 60505-0681 60505-0681-0 1 VIAL in 1 CARTON (60505-0681-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
CEFEPIME HYDROCHLORIDE cefepime hydrochloride INJECTABLE;INJECTION 065369 ANDA Apotex Corporation 60505-0681 60505-0681-4 10 VIAL in 1 CARTON (60505-0681-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (60505-0681-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 18, 2007TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jun 18, 2007TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jun 18, 2007TE:APRLD:No


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