FDA.reportPublic FDA data

Application 209043

Type
ANDA
Sponsor
SUNSHINE LAKE

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
0527-2381azithromycinAZITHROMYCIN MONOHYDRATELannett Company, Inc.ANDACurrent
0527-2381azithromycinAZITHROMYCIN MONOHYDRATELannett Company, Inc.ANDACurrent
0527-2381azithromycinAZITHROMYCIN MONOHYDRATELannett Company, Inc.ANDACurrent
0527-2381azithromycinAZITHROMYCIN MONOHYDRATELannett Company, Inc.ANDACurrent
0527-2381azithromycinAZITHROMYCIN MONOHYDRATELannett Company, Inc.ANDACurrent
0527-2381azithromycinAZITHROMYCIN MONOHYDRATELannett Company, Inc.ANDACurrent
48792-7871azithromycinAZITHROMYCIN MONOHYDRATESunshine Lake Pharma Co., Ltd.ANDACurrent