FDA.reportPublic FDA data

Application 009768

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLAQUENILHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-335PlaquenilHydroxychloroquine SulfateAvKARE, Inc.NDACurrent
43353-051Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-051Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-997PlaquenilHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-3432Hydroxychloroquine SulfateHydroxychloroquine SulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-562PlaquenilHydroxychloroquine SulfateConcordia Pharmaceuticals Inc.NDACurrent
63629-3343Hydroxychloroquine SulfateHydroxychloroquine SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3343Hydroxychloroquine SulfateHydroxychloroquine SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3343Hydroxychloroquine SulfateHydroxychloroquine SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-057Hydroxychloroquine SulfateHydroxychloroquine SulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
67296-1781PlaquenilHydroxychloroquine SulfateRedPharm Drug, Inc.NDACurrent
67296-1781PlaquenilHydroxychloroquine SulfateRedPharm Drug, Inc.NDACurrent
68151-0511PlaquenilHydroxychloroquine SulfateCarilion Materials ManagementNDACurrent
68788-7770Hydroxychloroquine SulfateHydroxychloroquine SulfatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7770Hydroxychloroquine SulfateHydroxychloroquine SulfatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
71205-448PlaquenilHydroxychloroquine SulfateProficient Rx LPNDACurrent
71610-473PlaquenilHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDACurrent
71610-473PlaquenilHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76787SUPPL 2023-12-13
76777SUPPL 2023-12-13
74891SUPPL 2023-07-26
74887SUPPL 2023-07-25
70985SUPPL2022-05-04
70979SUPPL2022-05-04
67437SUPPL2021-05-07
67399SUPPL2021-05-04
59358SUPPL2019-07-16
59357SUPPL2019-07-16
47021SUPPL2017-01-30
47020SUPPL2017-01-30
47019SUPPL2017-01-30
47027SUPPL2017-01-27
47026SUPPL2017-01-27
47025SUPPL2017-01-27
11881SUPPL2007-07-05
33006SUPPL2007-06-27