FDA.reportPublic FDA data

Application 065056

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINTABLET;ORAL500MGNoNo
002AMOXICILLINAMOXICILLINTABLET;ORAL875MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2263AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2263AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2264AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2264AmoxicillinAmoxicillinTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-112AmoxicillinAmoxicillinQPharma IncANDACurrent
42708-112AmoxicillinAmoxicillinQPharma IncANDACurrent
42708-112AmoxicillinAmoxicillinQPharma IncANDACurrent
50090-4929AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
70934-672AmoxicillinAmoxicillinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18326SUPPL2014-02-06
22307ORIG2003-07-31
8381ORIG2000-09-18