Application 216830

Type
NDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS20MG/250ML (0.08MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85107ORIG 2026-02-23
82425ORIG 2025-06-02
82426ORIG 2025-05-30