Application 214783

Type
NDA
Sponsor
KADMON PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REZUROCKBELUMOSUDILTABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
79802-200RezurockbelumosudilKadmon Pharmaceuticals, LLCNDACurrent
79802-200RezurockbelumosudilKadmon Pharmaceuticals, LLCNDACurrent
79802-200RezurockbelumosudilKadmon Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84809SUPPL 2026-01-21
80793SUPPL 2025-01-02
80790SUPPL 2025-01-02
78112SUPPL 2024-04-12
78109SUPPL 2024-04-11
76564SUPPL 2023-11-14
76556SUPPL 2023-11-13
68370ORIG2021-08-13
68135ORIG2021-07-20
68114ORIG2021-07-19