Application 018342

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELLCOVORINLEUCOVORIN CALCIUMTABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002WELLCOVORINLEUCOVORIN CALCIUMTABLET;ORALEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85561SUPPL 2026-03-30
85311SUPPL 2026-03-12
85312SUPPL 2026-03-10