FDA.reportPublic FDA data

Application 214581

Type
NDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET; ORAL200MGYesNo
002HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET; ORAL300MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70954-171Hydroxychloroquine SulfateHydroxychloroquine SulfateNovitium Pharma LLCNDACurrent
70954-171Hydroxychloroquine SulfateHydroxychloroquine SulfateNovitium Pharma LLCNDACurrent
70954-171Hydroxychloroquine SulfateHydroxychloroquine SulfateNovitium Pharma LLCNDACurrent
70954-172Hydroxychloroquine SulfateHydroxychloroquine SulfateNovitium Pharma LLCNDACurrent
70954-172Hydroxychloroquine SulfateHydroxychloroquine SulfateNovitium Pharma LLCNDACurrent
70954-172Hydroxychloroquine SulfateHydroxychloroquine SulfateNovitium Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79858SUPPL 2024-10-11
75490SUPPL 2023-09-15
75470SUPPL 2023-09-15
74892SUPPL 2023-07-26
74883SUPPL 2023-07-25
73155SUPPL2023-01-13
73153SUPPL2023-01-13
72403ORIG2022-10-17
69932ORIG2022-01-20
69900ORIG2022-01-19