FDA.reportPublic FDA data

Application 019101

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTANYL CITRATE PRESERVATIVE FREEFENTANYL CITRATEINJECTABLE;INJECTIONEQ 0.05MG BASE/MLYesYes
002FENTANYL CITRATEFENTANYL CITRATEINJECTABLE;INJECTIONEQ 0.025MG BASE/0.5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6024Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6024Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6024Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6025Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6025Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6025Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6026Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6026Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6026Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6027Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6027Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6027Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6028Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6028Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6028Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6029Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6029Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6029Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6030Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6030Fentanyl CitrateFentanyl CitrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6030Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
0641-6247Fentanyl CitrateFentanyl CitrateHikma Pharmaceuticals USA Inc.NDACurrent
72572-170Fentanyl CitrateFentanyl CitrateCivica, Inc.NDACurrent
72572-170Fentanyl CitrateFentanyl CitrateCivica, Inc.NDACurrent
72572-171Fentanyl CitrateFentanyl CitrateCivica, Inc.NDACurrent
72572-171Fentanyl CitrateFentanyl CitrateCivica, Inc.NDACurrent
72572-172Fentanyl CitrateFentanyl CitrateCivica, Inc.NDACurrent
81565-205Fentanyl CitrateFentanyl CitratePhlow Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84650SUPPL 2026-01-06
84560SUPPL 2025-12-29
83537SUPPL 2025-09-26
83536SUPPL 2025-09-26
79572SUPPL 2024-09-10
79571SUPPL 2024-09-10
76989SUPPL 2023-12-19
76887SUPPL 2023-12-18
73944SUPPL 2023-04-04
73943SUPPL 2023-04-04
60521SUPPL2019-10-10
60415SUPPL2019-10-09
57509SUPPL2019-02-13
57348SUPPL2019-01-25
46400SUPPL2016-12-21
46226SUPPL2016-12-20