FDA.reportPublic FDA data

Application 065098

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL200MG/5ML;EQ 28.5MG BASE/5MLNoNo
002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL400MG/5ML;EQ 57MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-927Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiummedsource pharmaceuticalsANDACurrent
53002-0050Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-0050Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRPK Pharmaceuticals, Inc.ANDACurrent
63187-542Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
63187-542Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
66685-1011Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1011Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1011Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1012Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1012Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1012Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
68071-4145Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8996Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8996Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8996Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9424Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9424Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9424Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent