FDA.reportPublic FDA data

Application 090549

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 250MG BASENoNo
002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9836Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9836Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9836Penicillin V PotassiumPenicillin V PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9837Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9837Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9837Penicillin V PotassiumPenicillin V PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3307Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3307Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3374Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3374Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3837Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
55700-572Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-572Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-572Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
59115-117Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
59115-117Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
59115-118Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
59115-118Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
68071-2457Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2515Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2778Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8242Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-3441Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-3535Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
72789-222Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-222Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-223Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-245Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent