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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 050755


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NDA 050755 describes AUGMENTIN ES-600, which is a drug marketed by Us Antibiotics and is included in one NDA. It is available from two suppliers. Additional details are available on the AUGMENTIN ES-600 profile page.

The generic ingredient in AUGMENTIN ES-600 is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 050755
Tradename:AUGMENTIN ES-600
Applicant:Us Antibiotics
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Pharmacology for NDA: 050755
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050755
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN ES-600 amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050755 NDA AUTHORIZED GENERIC RPK Pharmaceuticals, Inc. 53002-4716 53002-4716-1 200 mL in 1 BOTTLE (53002-4716-1)
AUGMENTIN ES-600 amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050755 NDA AUTHORIZED GENERIC RPK Pharmaceuticals, Inc. 53002-4716 53002-4716-2 75 mL in 1 BOTTLE (53002-4716-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Jun 22, 2001TE:ABRLD:Yes

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