FDA.reportPublic FDA data

Application 065419

Type
ANDA
Sponsor
TEVA PHARMS

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
0093-7148AzithromycinAzithromycin MonohydrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7149AzithromycinAzithromycin MonohydrateTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-548AzithromycinAzithromycin monohydrateRebel Distributors Corp.ANDACurrent
21695-549AzithromycinAzithromycin monohydrateRebel Distributors Corp.ANDACurrent
66116-524AzithromycinAzithromycin MonohydrateMedVantx, Inc.ANDACurrent
68788-9045AzithromycinAzithromycin MonohydratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9046AzithromycinAzithromycin MonohydratePreferred Pharmaceuticals, Inc.ANDACurrent