Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
LUPIN LIMITED
675923163
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LUPIN LIMITED
LUPIN LIMITED
LUPIN LIMITED
677600414
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenofibrate
Product Details
NDC Product Code
57297-361Application Number
ANDA090856Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 11, 2016FenofibrateActive
Code: U202363UOSClass: ACTIBQuantity: 145 mg in 1 1
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT