FDA.reportPublic FDA data

Application 065373

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9853Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9853Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9853Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
50090-0996Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-0996Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
53217-220Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAidarex Pharmaceuticals LLCANDACurrent
55700-538Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
59115-061Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
59115-061Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
68071-1603Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1603Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6829Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8299Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent