FDA.reportPublic FDA data

Application 065255

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINTABLET;ORAL875MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9285AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
0143-9285AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9285AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9285AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9951AmoxicillinAmoxicillinWest-Ward Pharmaceutical CorpANDACurrent
10544-434AmoxicillinAmoxicillinBlenheim Pharmacal, Inc.ANDACurrent
35356-983AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-011AmoxicillinAmoxicillinQPharma IncANDACurrent
42708-011AmoxicillinAmoxicillinQPharma IncANDACurrent
43063-885AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-885AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-885AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-885AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-885AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-885AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0711AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0712AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-5863AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-5863AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-5880AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
55289-707AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, InANDACurrent
55700-687AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-687AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-041AMOXILAMOXICILLINDIRECT RXANDACurrent
61919-041AMOXILAMOXICILLINDIRECT RXANDACurrent
63187-138AmoxicillinAmoxicillinProficient Rx LPANDACurrent
66336-074AmoxicillinAmoxicillinDispensing Solutions, Inc.ANDACurrent
67296-0628AmoxicillinAmoxicillinRedPharm Drug Inc.ANDACurrent
68788-0763AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1715AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-1715AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
72789-224AmoxicillinAmoxicillinPD-Rx Pharmaceuticals, Inc.ANDACurrent
76420-138AmoxicillinAmoxicillinAsclemed USA, Inc.ANDACurrent