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

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Covington
Express Scripts
Mallinckrodt
Boehringer Ingelheim
Julphar
Merck
AstraZeneca
McKesson

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050405

« Back to Dashboard

NDA 050405 describes KEFLEX, which is a drug marketed by Pragma Pharms Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the KEFLEX profile page.

The generic ingredient in KEFLEX is cephalexin. There are twenty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 050405
Tradename:KEFLEX
Applicant:Pragma Pharms Llc
Ingredient:cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050405
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 050405
Suppliers and Packaging for NDA: 050405
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KEFLEX cephalexin CAPSULE;ORAL 050405 NDA Fera Pharmaceuticals, LLC 48102-021 N 48102-021-50
KEFLEX cephalexin CAPSULE;ORAL 050405 NDA Pragma Pharmaceuticals, LLC 58463-011 N 58463-011-01

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 12, 2006TE:RLD:Yes

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Covington
Teva
Cipla
Chubb
Fuji
Daiichi Sankyo
Express Scripts
Julphar

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.