FDA.reportPublic FDA data

Application 074653

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0386Hydromorphone Hydrochloridehydromorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0386Hydromorphone Hydrochloridehydromorphone hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0386Hydromorphone Hydrochloridehydromorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-0386Hydromorphone Hydrochloridehydromorphone hydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-0386Hydromorphone Hydrochloridehydromorphone hydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
70166-250Hydromorphone Hydrochloridehydromorphone hydrochlorideLohxaANDACurrent
70166-250Hydromorphone Hydrochloridehydromorphone hydrochlorideLohxaANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76209ORIG 2023-11-03
8426ORIG1998-07-29