FDA.reportPublic FDA data

Application 065119

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL200MG/5MLNoNo
002AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL400MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4160AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4160AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4160AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4160AmoxicillinAmoxicillinTeva Pharmaceuticals USA,ANDACurrent
0093-4161AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4161AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4161AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4161AmoxicillinAmoxicillinTeva Pharmaceuticals USA,ANDACurrent
50090-4078AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-4078AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
68071-5148AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5148AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
71205-177AmoxicillinAmoxicillinProficient Rx LPANDACurrent
71205-177AmoxicillinAmoxicillinProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18329SUPPL2014-02-06