FDA.reportPublic FDA data

Application 065358

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL600MG/5ML;EQ 42.9MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-6139Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6139Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6139Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6139Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
21695-401Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRebel Distributors Corp.ANDACurrent
53217-359Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAidarex Pharmaceuticals LLCANDACurrent
68788-8157Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8956Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
71205-620Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent