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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Novartis
Argus Health
Queensland Health
UBS
Accenture
Chubb
Merck
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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062713

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NDA 062713 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 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-three suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 062713
Tradename:CEPHALEXIN
Applicant:Belcher Pharms
Ingredient:cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062713
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 062713
Suppliers and Packaging for NDA: 062713
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin CAPSULE;ORAL 062713 ANDA Blenheim Pharmacal, Inc. 10544-082 E 10544-082-20
CEPHALEXIN cephalexin CAPSULE;ORAL 062713 ANDA Blenheim Pharmacal, Inc. 10544-082 E 10544-082-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Jul 15, 1988TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Jul 15, 1988TE:ABRLD:No

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