FDA.reportPublic FDA data

Application 203824

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL875MG;EQ 125MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9249Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9249Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9249Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
45865-980Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassiummedsource pharmaceuticalsANDACurrent
50090-3179Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3179Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3414Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-653Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
59115-025Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
59115-025Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumHikma PharmaceuticalANDACurrent
61919-430AMOXICILLIN/CLAV POTAMOXICILLIN/CLAV POTDIRECT RXANDACurrent
61919-430AMOXICILLIN/CLAV POTAMOXICILLIN/CLAV POTDIRECT RXANDACurrent
61919-430AMOXICILLIN/CLAV POTAMOXICILLIN/CLAV POTDIRECT RXANDACurrent
68071-4967Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4967Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5026Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5026Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5057Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7805Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7805Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7805Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-147Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-253Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent