FDA.reportPublic FDA data

Application 065218

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 600MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50111-789AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-789AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-789AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-789AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-789AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
70518-0713AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0713AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0713AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0713AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0713AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0713AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent