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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 065378


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NDA 065378 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 065378
Tradename:AMOXICILLIN
Applicant:Sandoz
Ingredient:amoxicillin
Patents:0
Pharmacology for NDA: 065378
Medical Subject Heading (MeSH) Categories for 065378
Suppliers and Packaging for NDA: 065378
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065378 ANDA Sandoz Inc 0781-6156 0781-6156-46 100 mL in 1 BOTTLE (0781-6156-46)
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065378 ANDA Sandoz Inc 0781-6156 0781-6156-52 50 mL in 1 BOTTLE (0781-6156-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Mar 26, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML
Approval Date:Mar 26, 2007TE:ABRLD:No

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