FDA.reportPublic FDA data

Application 022276

Type
NDA
Sponsor
EXELA PHARMA SCIENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/10ML (2.5MG/ML)NoNo
002NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INTRAVENOUS20MG/200ML (0.1MG/ML)NoNo
003NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INTRAVENOUS40MG/200ML (0.2MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9542Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9542Nicardipine HydrochlorideNicardipine HydrochlorideWest-Ward Pharmaceuticals CorpNDACurrent
0143-9593Nicardipine HydrochlorideNicardipine HydrochlorideWest-Ward Pharmaceuticals CorpNDACurrent
0143-9633Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9633Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9634Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9634Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9689Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0143-9689Nicardipine HydrochlorideNicardipine HydrochlorideWest-Ward Pharmaceuticals CorpNDACurrent
0143-9689Nicardipine HydrochlorideNicardipine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
51662-1482NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1482NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82822SUPPL 2025-07-14
82821SUPPL 2025-07-14
80100SUPPL 2024-11-04
80099SUPPL 2024-11-04
69828SUPPL2022-01-11
69827SUPPL2022-01-11
67647SUPPL2021-06-01
65840SUPPL2021-01-07
53936ORIG2018-05-01
52436APPL2018-02-06
45417SUPPL2016-09-29
45394SUPPL2016-09-26
7159SUPPL2016-04-11
17187SUPPL2016-04-08
38486SUPPL2009-01-14
7158SUPPL2009-01-12
44724ORIG2008-10-09
21978ORIG2008-10-09
7157ORIG2008-07-31
17186ORIG2008-07-29