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Amoxicillin and Clavulanate Potassium

These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Extended Release Tablets safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Extended Release Tablets Amoxicillin and Clavulanate Potassium Extended Release Tablets Initial U.S. Approval: 2002 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.(1)

Approved
Approval ID

fc4bb4b0-9330-4701-a600-199c42fb3255

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2014

Manufacturers
FDA

Dr. Reddy's Laboratories Inc

DUNS: 802315887

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

amoxicillin and clavulanate potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-220
Application NumberNDA050785
Product Classification
M
Marketing Category
C73594
G
Generic Name
amoxicillin and clavulanate potassium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2014
FDA Product Classification

INGREDIENTS (12)

AMOXICILLINActive
Quantity: 562.5 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 62.5 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
AMOXICILLIN SODIUMActive
Quantity: 437.5 mg in 1 1
Code: 544Y3D6MYH
Classification: ACTIM
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT

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