FDA.reportPublic FDA data

Application 219843

Type
NDA
Sponsor
ROSEMONT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATMEKSIMETHOCARBAMOLSUSPENSION;ORAL750MG/5MLYesYes
002ATMEKSIMETHOCARBAMOLSUSPENSION;ORAL750MG(5ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83011ORIG 2025-08-01
83006ORIG 2025-07-31