FDA.reportPublic FDA data

Application 065291

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINCAPSULE;ORAL250MGNoNo
002AMOXICILLINAMOXICILLINCAPSULE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9938AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
0143-9938AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9939AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9939AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9939AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
10544-619AmoxicillinAmoxicillinBlenheim Pharmacal, Inc.ANDACurrent
43063-015AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-015AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-017AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-017AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-017AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-017AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0301AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0301AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0302AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0303AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0303AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0304AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50436-7218AmoxicillinAmoxicillinUnit Dose ServicesANDACurrent
55700-075AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-075AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-075AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-075AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-075AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-075AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
59115-041AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
59115-041AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
59115-041AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
59115-042AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
63874-101AmoxicillinAmoxicillinAltura Pharmaceuticals, Inc.ANDACurrent
63874-102AmoxicillinAmoxicillinAltura Pharmaceuticals, Inc.ANDACurrent
67296-0220AmoxicillinAmoxicillinRedPharm Drug Inc.ANDACurrent
67296-0986AmoxicillinAmoxicillinRedPharm Drug, Inc.ANDACurrent
67296-0986AmoxicillinAmoxicillinRedPharm Drug, Inc.ANDACurrent
68788-9032AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9033AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
70934-310AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-310AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
72789-225AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-254AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent