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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 065271


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NDA 065271 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, Dava Pharms Inc, Hikma, Wockhardt Bio Ag, Apothecon, Aurobindo Pharma, 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-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065271
Tradename:AMOXICILLIN
Applicant:Aurobindo
Ingredient:amoxicillin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065271
Medical Subject Heading (MeSH) Categories for 065271
Suppliers and Packaging for NDA: 065271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin CAPSULE;ORAL 065271 ANDA NorthStar Rx LLC 16714-298 16714-298-01 100 CAPSULE in 1 BOTTLE (16714-298-01)
AMOXICILLIN amoxicillin CAPSULE;ORAL 065271 ANDA NorthStar Rx LLC 16714-298 16714-298-02 500 CAPSULE in 1 BOTTLE (16714-298-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Nov 9, 2005TE:ABRLD:No

Profile for product number 002

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

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