FDA.reportPublic FDA data

Application 201691

Type
ANDA
Sponsor
ALKALOIDA ZRT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5388HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEA-S Medication SolutionsANDACurrent
50090-5388HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEA-S Medication SolutionsANDACurrent
57664-761HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATESun Pharmaceutical Industries, Inc.ANDACurrent
57664-761HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATESun Pharmaceutical Industries, Inc.ANDACurrent
57664-761Hydroxychloroquine sulfateHydroxychloroquine sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
57664-761Hydroxychloroquine sulfateHydroxychloroquine sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
57664-761Hydroxychloroquine sulfateHydroxychloroquine sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
57664-761HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATESun Pharmaceutical Industries, Inc.ANDACurrent
57664-761HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATESun Pharmaceutical Industries, Inc.ANDACurrent
72189-085HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDIRECT RXANDACurrent
72789-026HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-026HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-026HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-026HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-026Hydroxychloroquine sulfateHydroxychloroquine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62504ORIG2020-04-08
62503ORIG2020-04-08