FDA.reportPublic FDA data

Application 019998

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CHEMETSUCCIMERCAPSULE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55292-201ChemetsuccimerRECORDATI RARE DISEASES, INC.NDACurrent
55292-201ChemetsuccimerRECORDATI RARE DISEASES, INC.NDACurrent
55292-201ChemetsuccimerRecordati Rare Diseases, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79648SUPPL 2024-09-18
79636SUPPL 2024-09-17
55881SUPPL2018-10-11
55783SUPPL2018-10-02
19924SUPPL2010-10-19
34176SUPPL2007-07-16
1894SUPPL2007-07-16