Application 050406

Type
NDA
Sponsor
PRAGMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KEFLEXCEPHALEXINFOR SUSPENSION;ORALEQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002KEFLEXCEPHALEXINFOR SUSPENSION;ORALEQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons*YesNo
003KEFLEXCEPHALEXINFOR SUSPENSION;ORALEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons*YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85315SUPPL 2026-03-10
85289SUPPL 2026-03-09
56960SUPPL2018-12-21
56902SUPPL2018-12-20