FDA.reportPublic FDA data

Application 065223

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50111-788AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-788AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-788AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-788AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-788AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-788AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
53002-0470AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-0470AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-6221AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53217-161AzithromycinAzithromycinAidarex Pharmaceuticals LLCANDACurrent
61919-383AZITHROMYCINAZITHROMYCINDirectRXANDACurrent
63187-189AzithromycinAzithromycinProficient Rx LPANDACurrent
68071-1584AzithromycinAzithromycinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4774AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4774AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4774AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9311AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9311AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70518-0599AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent