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FDA Product

Amoxicillin and Clavulanate Potassium

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amoxicillin and Clavulanate Potassium

21695-401

Regulatory Information

21695-401

ANDA065358

C73584

October 9, 2009

USA

AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

118802834

Active Ingredients

AMOXICILLIN

Quantity: 600 mg in 5 mL

Code: 804826J2HU

Class Code: ACTIB

CLAVULANATE POTASSIUM

Quantity: 42.9 mg in 5 mL

Code: Q42OMW3AT8

Class Code: ACTIB

CARBOXYMETHYLCELLULOSE SODIUM

Code: K679OBS311

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CITRIC ACID

Code: 2968PHW8QP

Class Code: IACT

COLLOIDAL SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

AMOXICILLIN

Code: 804826J2HU

CLAVULANIC ACID

Code: 23521W1S24

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