Application 217812

Type
NDA
Sponsor
HIKMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS40MG/20ML (2MG/ML)YesYes

Documents

DocumentSubmission typeDate
84702SUPPL 2026-01-07
84588SUPPL 2025-12-29
79819ORIG 2024-10-07
76858ORIG 2023-12-15
76844ORIG 2023-12-15