Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fresenius Kabi Austria GmbH
Fresenius Kabi Austria GmbH
303448575
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cleviprex
Product Details
NDC Product Code
18124-011Application Number
NDA022156Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 28, 2018SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGVClass: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CPClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ClevidipineActive
Code: 19O2GP3B7QClass: ACTIBQuantity: 0.5 mg in 1 mL