FDA.reportPublic FDA data

Application 065405

Type
ANDA
Sponsor
WOCKHARDT

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
21695-013AZITHROMYCINAZITHROMYCINRebel Distributors Corp.ANDACurrent
33261-879AZITHROMYCINAZITHROMYCINAidarex Pharmaceuticals LLCANDACurrent
50268-099AzithromycinAzithromycinAvPAKANDACurrent
50268-099AzithromycinAzithromycinAvPAKANDACurrent
50268-099AzithromycinAzithromycinAvPAKANDACurrent
53002-0472AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-5221AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
55045-3693AZITHROMYCINAZITHROMYCINDispensing Solutions, Inc.ANDACurrent
55648-964AZITHROMYCINAZITHROMYCINWOCKHARDT LIMITEDANDACurrent
62980-964AzithromycinAzithromycinVivimed Labs LimitedANDACurrent
63187-594AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-594AzithromycinAzithromycinProficient Rx LPANDACurrent
63629-7784AzithromycinAzithromycinBryant Ranch PrepackANDACurrent
63629-7784AzithromycinAzithromycinBryant Ranch PrepackANDACurrent
63629-7784AzithromycinAzithromycinBryant Ranch PrepackANDACurrent
64679-964AzithromycinAzithromycinWockhardt USA LLC.ANDACurrent
64679-964AzithromycinAzithromycinWockhardt USA LLC.ANDACurrent
64679-964AzithromycinAzithromycinWockhardt USA LLC.ANDACurrent
64679-964AzithromycinAzithromycinWockhardt USA LLC.ANDACurrent
68071-4364AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4364AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4680AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68258-3012AZITHROMYCINAZITHROMYCINDispensing Solutions Inc.ANDACurrent
68788-9078AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent