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Amoxicillin and Clavulanate Potassium

Rx Only These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE POTASSIUM for oral suspension Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

25e641d0-a5de-4163-938a-ea52c4bfa48e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 9, 2023

Manufacturers
FDA

Morton Grove Pharmaceuticals, Inc.

DUNS: 801897505

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 Code60432-065
Application NumberANDA065431
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification

INGREDIENTS (7)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 62.5 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
AMOXICILLINActive
Quantity: 250 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM

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Amoxicillin and Clavulanate Potassium - FDA Drug Approval Details