FDA.reportPublic FDA data

Application 212535

Type
NDA
Sponsor
AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOURESSCYSTEINE HYDROCHLORIDESOLUTION;INTRAVENOUS500MG/10ML (50MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-9645CYSTEINE HYDROCHLORIDEcysteine hydrochlorideBaxter Healthcare CorporationNDACurrent
76014-006Nouresscysteine hydrochlorideAvadel Legacy Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62149ORIG2020-03-16
61295ORIG2019-12-17
61276ORIG2019-12-16