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Generated: April 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065152

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

Summary for NDA: 065152

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065152


Suppliers and Packaging for NDA: 065152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 065152 ANDA Blenheim Pharmacal, Inc. 10544-025 10544-025-10 10 CAPSULE in 1 BOTTLE (10544-025-10)
CAPSULE;ORAL 065152 ANDA Blenheim Pharmacal, Inc. 10544-025 10544-025-14 14 CAPSULE in 1 BOTTLE (10544-025-14)

Summary for product number 001

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

Summary for product number 002

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

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