Application 218343

Type
NDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDEPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASICSOLUTION;INTRAVENOUS1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82321ORIG 2025-05-27
79246ORIG 2024-07-29
79237ORIG 2024-07-29