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Details for New Drug Application (NDA): 090836

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NDA 090836 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: 090836

Tradename:
CEPHALEXIN
Applicant:
Alkem Labs Ltd
Ingredient:
cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090836

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 090836

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN
cephalexin
CAPSULE;ORAL 090836 ANDA Blenheim Pharmacal, Inc. 10544-529 10544-529-12 12 CAPSULE in 1 BOTTLE (10544-529-12)
CEPHALEXIN
cephalexin
CAPSULE;ORAL 090836 ANDA Blenheim Pharmacal, Inc. 10544-529 10544-529-21 21 CAPSULE in 1 BOTTLE (10544-529-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Dec 20, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Dec 20, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 333MG BASE
Approval Date:Mar 29, 2013TE:RLD:No


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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.

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