FDA.reportPublic FDA data

Application 022156

Type
NDA
Sponsor
CHIESI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEVIPREXCLEVIDIPINEEMULSION;INTRAVENOUS25MG/50ML (0.5MG/ML)YesYes
002CLEVIPREXCLEVIDIPINEEMULSION;INTRAVENOUS50MG/100ML (0.5MG/ML)YesYes
003CLEVIPREXCLEVIDIPINEEMULSION;INTRAVENOUS125MG/250ML (0.5MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-610CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-610CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-610CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-610CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-610CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-610CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-611CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-611CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-611CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-611CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-611CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-611CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-612CleviprexclevipidineChiesi USA, Inc.NDACurrent
10122-612CleviprexclevipidineChiesi USA, Inc.NDACurrent
18124-011CleviprexclevidipineFresenius Kabi Austria GmbHNDACurrent
18124-011CleviprexclevidipineFresenius Kabi Austria GmbHNDACurrent
18124-011CleviprexclevidipineFresenius Kabi Austria GmbHNDACurrent
65293-005CleviprexclevidipineThe Medicines CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67109SUPPL2021-04-19
67101SUPPL2021-04-19
29334SUPPL2011-12-14
38316SUPPL2011-12-13
44686ORIG2008-09-23
21948ORIG2008-09-23
29333ORIG2008-08-08