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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 065256


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NDA 065256 describes AMOXICILLIN, which is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Hikma, Apothecon, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, and Teva Pharms Usa, and is included in eighty-five NDAs. It is available from thirty-five suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065256
Tradename:AMOXICILLIN
Applicant:Aurobindo
Ingredient:amoxicillin
Patents:0
Pharmacology for NDA: 065256
Medical Subject Heading (MeSH) Categories for 065256
Suppliers and Packaging for NDA: 065256
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin TABLET;ORAL 065256 ANDA QPharma Inc 42708-078 42708-078-20 20 TABLET, FILM COATED in 1 BOTTLE (42708-078-20)
AMOXICILLIN amoxicillin TABLET;ORAL 065256 ANDA A-S Medication Solutions 50090-0709 50090-0709-0 20 TABLET, FILM COATED in 1 BOTTLE (50090-0709-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 9, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength875MG
Approval Date:Nov 9, 2005TE:ABRLD:No

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