FDA.reportPublic FDA data

Application 208843

Type
NDA
Sponsor
ADDMEDICA SAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIKLOSHYDROXYUREATABLET;ORAL100MGYesNo
002SIKLOSHYDROXYUREATABLET;ORAL1GMYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71770-100SikloshydroxyureaMedunikNDACurrent
71770-100SikloshydroxyureaMedunikNDACurrent
71770-105SikloshydroxyureaMedunikNDACurrent
71770-105SikloshydroxyureaMedunikNDACurrent
71770-105SikloshydroxyureaMedunikNDACurrent
71770-120SikloshydroxyureaMedunikNDACurrent
71770-120SikloshydroxyureaMedunikNDACurrent
71770-120SikloshydroxyureaMedunikNDACurrent
71770-120SikloshydroxyureaMedunikNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81079SUPPL 2025-02-06
76683SUPPL 2023-11-29
76679SUPPL 2023-11-29
76678SUPPL 2023-11-29
69528SUPPL2021-12-10
69525SUPPL2021-12-10
69515SUPPL2021-12-08
58842SUPPL2019-05-23
58841SUPPL2019-05-23
58840SUPPL2019-05-23
58261SUPPL2019-04-09
56889SUPPL2018-12-20
54775ORIG2018-07-06
50925ORIG2017-12-27
50818ORIG2017-12-21
50817ORIG2017-12-21