FDA.reportPublic FDA data

Application 061931

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL125MG/5MLNoNo
002AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL250MG/5MLNoYes
003AMOXICILLIN PEDIATRICAMOXICILLINFOR SUSPENSION;ORAL50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4150AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4150AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4150AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4155AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4155AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4155AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4155AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-384AmoxicillinAmoxicillinRebel Distributors Corp.ANDACurrent
21695-385AmoxicillinAmoxicillinRebel Distributors Corp.ANDACurrent
50090-1807AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-3005AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
53002-2091AmoxicillinAmoxicillinRPK Pharmaceuticals, Inc.ANDACurrent
53217-312AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
53217-314AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
61919-018AMOXICILLINamoxicillin powder, for suspensionDirect RXANDACurrent
63187-186AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-186AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-186AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-200AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-200AmoxicillinAmoxicillinProficient Rx LPANDACurrent
66116-223AmoxicillinAmoxicillinMedVantx, Inc.ANDACurrent
66267-994AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-994AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-994AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1526AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1526AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1526AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2558AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4196AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4696AmoxicillinAmoxicillinNuCare Pharmaceuticals,InANDACurrent
68071-4696AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4696AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent