FDA.reportPublic FDA data

Application 211147

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 100MG BASE/5MLNoNo
002AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 200MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4458AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-4458AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-4458AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-6267AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
68071-4711AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4711AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4779AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4779AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4779AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4785AzithromycinAzithromycinNuCare Pharmaceuticals,InANDACurrent
68071-4785AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4785AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7307AzithromycinAzithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7307AzithromycinAzithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7320AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7320AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8229AzithromycinAzithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-8246AzithromycinAzithromycinPreferred Pharmaceuticals Inc.ANDACurrent
70518-2075AzithromycinAzithromycinREMEDYREPACK INC.ANDACurrent
70710-1457AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1457AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1457AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1457AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1458AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1458AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1458AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1458AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1459AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1459AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1459AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1459AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1460AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1460AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1460AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1460AzithromycinAzithromycinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1422AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1422AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1422AzithromycinAzithromycinZydus Lifesciences LimitedANDACurrent
70771-1422AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1423AzithromycinAzithromycinZydus Lifesciences LimitedANDACurrent
70771-1423AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1423AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1423AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1424AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1424AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1424AzithromycinAzithromycinZydus Lifesciences LimitedANDACurrent
70771-1424AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1425AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1425AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
70771-1425AzithromycinAzithromycinZydus Lifesciences LimitedANDACurrent
70771-1425AzithromycinAzithromycinCadila Healthcare LimitedANDACurrent
71205-216AzithromycinAzithromycinProficient Rx LPANDACurrent
71205-216AzithromycinAzithromycinProficient Rx LPANDACurrent
71205-216AzithromycinAzithromycinProficient Rx LPANDACurrent