FDA.reportPublic FDA data

Application 065378

Type
ANDA
Sponsor
SANDOZ

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-6156AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6156AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6156AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6156AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6156AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6157AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6157AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6157AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6157AmoxicillinAmoxicillinSandoz IncANDACurrent
0781-6157AmoxicillinAmoxicillinSandoz IncANDACurrent
50090-5215AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
53002-1369AmoxicillinAmoxicillinRPK Pharmaceuticals, Inc.ANDACurrent
53002-1369AmoxicillinAmoxicillinRPK Pharmaceuticals, Inc.ANDACurrent
55700-467AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-672AMOXICILLINAMOXICILLINDIRECTRXANDACurrent
67253-147AmoxicillinAmoxicillinDAVA Pharmaceuticals IncANDACurrent
67253-149AmoxicillinAmoxicillinDAVA Pharmaceuticals IncANDACurrent
68071-1826AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4192AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5127AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5127AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
71205-436AmoxicillinAmoxicillinProficient Rx LPANDACurrent