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FDA Approval

AUGMENTIN ES-600

CompanyUSAntibiotics, LLC (DUNS: 118085486)

Effective Date

October 28, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Clavulanic acid(42.9 mg in 5 mL)

Amoxicillin(600 mg in 5 mL)

Manufacturing Establishments (1)

USAntibiotics, LLC

Labeler

USAntibiotics, LLC

DUNS Number

118085486

Products (1)

AUGMENTIN ES-600

NDC Product Code

81964-003

Application Number

NDA050755

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 8, 2022

Ingredients

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

Clavulanic acidActive

Code: Q42OMW3AT8Class: ACTIMQuantity: 42.9 mg in 5 mL

AmoxicillinActive

Code: 804826J2HUClass: ACTIMQuantity: 600 mg in 5 mL

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACT

CARBOXYMETHYLCELLULOSE SODIUMInactive

Code: K679OBS311Class: IACT

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