FDA.reportPublic FDA data

Application 213342

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGNoNo
002HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL100MGNoNo
003HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL300MGNoNo
004HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8401Hydroxychloroquine SulfateHydroxychloroquine SulfateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8401Hydroxychloroquine SulfateHydroxychloroquine SulfateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
16729-485Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.ANDACurrent
16729-485Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.ANDACurrent
16729-485Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.,ANDACurrent
16729-485Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.,ANDACurrent
16729-561Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.,ANDACurrent
16729-562Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.,ANDACurrent
16729-563Hydroxychloroquine SulfateHydroxychloroquine SulfateAccord Healthcare, Inc.,ANDACurrent
50090-6280Hydroxychloroquine SulfateHydroxychloroquine SulfateA-S Medication SolutionsANDACurrent