Application 217472

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCURONIUM BROMIDEROCURONIUM BROMIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)YesYes
002ROCURONIUM BROMIDEROCURONIUM BROMIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82528ORIG 2025-06-10
82514ORIG 2025-06-10