FDA.reportPublic FDA data

Application 040104

Type
ANDA
Sponsor
SANDOZ

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
0615-8218Hydroxychloroquine SulfateHydroxychloroquine SulfateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8218Hydroxychloroquine SulfateHydroxychloroquine SulfateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1407Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0781-5994Hydroxychloroquine SulfateHydroxychloroquine SulfateSandoz IncANDACurrent
0904-6508Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
0904-6884Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
0904-6884Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
0904-6884Hydroxychloroquine SulfateHydroxychloroquine SulfateMajor PharmaceuticalsANDACurrent
16714-474Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
16714-753Hydroxychloroquine SulfateHydroxychloroquine SulfateNorthstar RxLLCANDACurrent
43353-103Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67296-1780Hydroxychloroquine SulfateHydroxychloroquine SulfateRedPharm Drug, Inc.ANDACurrent
67296-1780Hydroxychloroquine SulfateHydroxychloroquine SulfateRedPharm Drug, Inc.ANDACurrent
71610-047Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-047Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62483SUPPL2020-04-08
62482SUPPL2020-04-08