Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cipher Pharmaceuticals Inc
200224645
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lipofen
Product Details
NDC Product Code
62559-306Application Number
NDA021612Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 23, 2021FenofibrateActive
Code: U202363UOSClass: ACTIBQuantity: 150 mg in 1 1
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369MClass: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPEClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
Lipofen
Product Details
NDC Product Code
62559-305Application Number
NDA021612Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 23, 2021GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8Class: IACT
FenofibrateActive
Code: U202363UOSClass: ACTIBQuantity: 50 mg in 1 1
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369MClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPEClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT