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Serving leading biopharmaceutical companies globally:

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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065152

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NDA 065152 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Apothecon, Aurobindo Pharma Ltd, Barr, Belcher Pharms, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Orchid Hlthcare, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Yung Shin Pharm, Hikma Pharms, and Vitarine, and is included in forty-nine NDAs. It is available from sixty-one suppliers. Additional details are available on the CEPHALEXIN profile page.

The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 065152
Tradename:CEPHALEXIN
Applicant:Yung Shin Pharm
Ingredient:cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065152
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065152
Suppliers and Packaging for NDA: 065152
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin CAPSULE;ORAL 065152 ANDA Blenheim Pharmacal, Inc. 10544-025 10544-025-28 28 CAPSULE in 1 BOTTLE (10544-025-28)
CEPHALEXIN cephalexin CAPSULE;ORAL 065152 ANDA Blenheim Pharmacal, Inc. 10544-025 10544-025-40 40 CAPSULE in 1 BOTTLE (10544-025-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Feb 24, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Feb 24, 2005TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Fuji
Cipla
Chinese Patent Office
Julphar
Argus Health
Federal Trade Commission
Merck
QuintilesIMS

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