FDA.reportPublic FDA data

Application 065191

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9981Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9981Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9981Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9982Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9982Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9982Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
50090-0831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0832Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0832Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0832Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0928Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0928Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
53217-286Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAidarex Pharmaceuticals LLCANDACurrent
59115-023Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
59115-023Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
59115-024Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
59115-024Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
61919-391AUGMENTINAMOX/CLAV.POT.ORAL SUSPDirect_RxANDACurrent
63187-826Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-826Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-1618Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNucare Pharmaceuticals,Inc.ANDACurrent
68071-1618Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNucare Pharmaceuticals,Inc.ANDACurrent
68071-1619Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1619Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1619Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1812Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1865Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1865Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4170Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5152Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5152Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0598Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0598Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0598Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0598Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0598Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent