FDA.report

Application 065322

Type
ANDA
Sponsor
HIKMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL250MG/5MLNoNo
002AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL125MG/5MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9888AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9888AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9888AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
0143-9889AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9889AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9889AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
33261-460AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
33261-602AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
33261-726AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
50090-0404AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0405AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0405AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0406AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0407AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0407AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0411AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-2251AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-2251AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
52959-613AmoxicillinAmoxicillinH.J. Harkins Company, Inc.ANDACurrent
59115-044AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
59115-046AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
61919-015AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-015AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-716AMOXILAMOXICILLINDirect_RxANDACurrent
61919-716AMOXILAMOXICILLINDirect_RxANDACurrent
63187-029AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-029AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-029AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-195AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-195AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-295AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-295AmoxicillinAmoxicillinProficient Rx LPANDACurrent
66267-993AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-993AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1760AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1760AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1760AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1761AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1761AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1761AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2364AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
72189-385AmoxilAmoxicillin Oral SuspDirectRxANDACurrent