FDA.reportPublic FDA data

Application 065509

Type
ANDA
Sponsor
APOTEX CORP

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
50090-1655Azithromycin DihydrateazithromycinA-S Medication SolutionsANDACurrent
50268-104Azithromycin DihydrateazithromycinAvPAKANDACurrent
50436-2852Azithromycin DihydrateazithromycinUnit Dose ServicesANDACurrent
53002-2221Azithromycin DihydrateazithromycinRPK Pharmaceuticals, Inc.ANDACurrent
68788-9521Azithromycin DihydrateazithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9521Azithromycin DihydrateazithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
70882-118Azithromycin DihydrateazithromycinCambridge Therapeutics Technologies, LLCANDACurrent