FDA.reportPublic FDA data

Application 065400

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-162azithromycin monohydrateazithromycin monohydrateLUPIN LIMITEDANDACurrent
60687-314Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-314Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-314Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-314Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
68180-162azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-162azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-162azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-162azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-162azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-863azithromycin dihydrateazithromycin dihydrateLupin Pharmaceuticals, Inc.ANDACurrent