FDA.reportPublic FDA data

Application 208085

Type
NDA
Sponsor
ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XTRELUSGUAIFENESIN; HYDROCODONE BITARTRATETABLET;ORAL400MG;5MGYesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84681SUPPL 2026-01-06
84538SUPPL 2025-12-23
77018SUPPL 2023-12-19
76923SUPPL 2023-12-18
76922SUPPL 2023-12-18
56742ORIG2018-12-14
56299SUPPL2018-11-06
56241SUPPL2018-11-01
53865ORIG2018-04-27
53822ORIG2018-04-26