TRICOR — FDA application NDA021656

Application NDA021656 · type NDA · FDA status: approved · original approval 2004-11-05

Listed sponsor: ABBVIE · ABBV company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	TRICOR	FENOFIBRATE	TABLET	ORAL	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
002	TRICOR	FENOFIBRATE	TABLET	ORAL	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

No Orange Book patent or exclusivity listings joined to this application.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.