FDA.reportPublic FDA data

Application 065399

Type
ANDA
Sponsor
LUPIN LTD

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
0904-6909azithromycin monohydrateazithromycin monohydrateMajor PharmaceuticalsANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-713azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-715azithromycin monohydrateazithromycin monohydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2334azithromycin dihydrateazithromycin dihydrateA-S Medication SolutionsANDACurrent
50436-3136azithromycin monohydrateazithromycin monohydrateUnit Dose ServicesANDACurrent
53002-3221azithromycin monohydrateazithromycin monohydrateRPK Pharmaceuticals, Inc.ANDACurrent
53217-403azithromycin monohydrateazithromycin monohydrateAidarex Pharmaceuticals LLCANDACurrent
55700-832azithromycin monohydrateazithromycin monohydrateQuality Care Products, LLCANDACurrent
57297-161azithromycin monohydrateazithromycin monohydrateLUPIN LIMITEDANDACurrent
60687-271Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-271Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-271Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-271Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
60687-271Azithromycin MonohydrateAzithromycin MonohydrateAmerican Health PackagingANDACurrent
61919-096AZITHROMYCIN MONOHYDRATEAZITHROMYCIN MONOHYDRATEDIRECT RXANDACurrent
61919-096AZITHROMYCIN MONOHYDRATEAZITHROMYCIN MONOHYDRATEDIRECT RXANDACurrent
68071-3168azithromycin monohydrateazithromycin monohydrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3169azithromycin monohydrateazithromycin monohydrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3169azithromycin monohydrateazithromycin monohydrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3187azithromycin monohydrateazithromycin monohydrateNuCare Pharmaceuticals,Inc.ANDACurrent
68180-161azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-161azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-161azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-161azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-161azithromycin monohydrateazithromycin monohydrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-862azithromycin dihydrateazithromycin dihydrateLupin Pharmaceuticals, Inc.ANDACurrent
70518-3453azithromycin monohydrateazithromycin monohydrateREMEDYREPACK INC.ANDACurrent