Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Dow
Federal Trade Commission
Express Scripts
US Army
Julphar
Deloitte
Healthtrust
Chinese Patent Office

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203704

« Back to Dashboard

NDA 203704 describes CEFEPIME HYDROCHLORIDE, which is a drug marketed by Acs Dobfar, Fosun Pharma, Hospira Inc, Qilu Pharm Co Ltd, and Sagent Pharms, 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 203704
Tradename:CEFEPIME HYDROCHLORIDE
Applicant:Qilu Pharm Co Ltd
Ingredient:cefepime hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203704
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 203704
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFEPIME HYDROCHLORIDE cefepime hydrochloride INJECTABLE;INJECTION 203704 ANDA Apotex Corp. 60505-6144 N 60505-6144-4
CEFEPIME HYDROCHLORIDE cefepime hydrochloride INJECTABLE;INJECTION 203704 ANDA Apotex Corp. 60505-6145 N 60505-6145-4

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Feb 1, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Feb 1, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Feb 1, 2016TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Medtronic
Cipla
Fuji
Teva
Healthtrust
US Department of Justice
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.