FDA.reportPublic FDA data

Application 207566

Type
ANDA
Sponsor
CSPC OUYI

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
51224-222Azithromycin dihydrateAzithromycin dihydrateTAGI Pharma, Inc.ANDACurrent
51224-222Azithromycin dihydrateAzithromycin dihydrateTAGI Pharma, Inc.ANDACurrent
51224-222Azithromycin dihydrateAzithromycin dihydrateTAGI Pharma, Inc.ANDACurrent
70518-3249Azithromycin dihydrateAzithromycin dihydrateREMEDYREPACK INC.ANDACurrent
70518-3249Azithromycin dihydrateAzithromycin dihydrateREMEDYREPACK INC.ANDACurrent