Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Chiesi USA, Inc.
088084228
Products2
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
10122-610Application Number
NDA022156Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 6, 2022ClevidipineActive
Code: 19O2GP3B7QClass: ACTIBQuantity: 0.5 mg in 1 mL
OLEIC ACIDInactive
Code: 2UMI9U37CPClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGVClass: IACT
Cleviprex
Product Details
NDC Product Code
10122-611Application Number
NDA022156Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 6, 2022EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
ClevidipineActive
Code: 19O2GP3B7QClass: ACTIBQuantity: 0.5 mg in 1 mL
OLEIC ACIDInactive
Code: 2UMI9U37CPClass: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGVClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT