FDA.reportPublic FDA data

Application 040657

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

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
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
16714-110Hydroxychloroquine sulfateHydroxychloroquine sulfateNorthstar Rx LLC.ANDACurrent
50090-5573Hydroxychloroquine sulfateHydroxychloroquine sulfateA-S Medication SolutionsANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal Health 107, LLCANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal HealthANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal HealthANDACurrent
55154-2074Hydroxychloroquine sulfateHydroxychloroquine sulfateCardinal HealthANDACurrent
61919-132HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDIRECT RXANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson Corporation dba SKY PackagingANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson Corporation dba SKY PackagingANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson Corporation dba SKY PackagingANDACurrent
63739-777Hydroxychloroquine sulfateHydroxychloroquine sulfateMcKesson CorporationANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateCadila Healthcare LimitedANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateCadila Healthcare LimitedANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Lifesciences LimitedANDACurrent
65841-633Hydroxychloroquine sulfateHydroxychloroquine sulfateCadila Healthcare LimitedANDACurrent
68071-2332Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2912Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4648Hydroxychloroquine sulfateHydroxychloroquine sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68084-269Hydroxychloroquine SulfateHydroxychloroquine SulfateAmerican Health PackagingANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-096Hydroxychloroquine sulfateHydroxychloroquine sulfateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7747Hydroxychloroquine sulfateHydroxychloroquine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7747Hydroxychloroquine sulfateHydroxychloroquine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7747Hydroxychloroquine sulfateHydroxychloroquine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71335-0897Hydroxychloroquine sulfateHydroxychloroquine sulfateBryant Ranch PrepackANDACurrent
71610-506Hydroxychloroquine sulfateHydroxychloroquine sulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
82009-045Hydroxychloroquine sulfateHydroxychloroquine sulfateQuallent Pharmaceuticals Health LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62478SUPPL2020-04-08
62477SUPPL2020-04-08