NIASPAN / NIASPAN TITRATION STARTER PACK — FDA application NDA020381

Application NDA020381 · type NDA · FDA status: approved · original approval 1997-07-28

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	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE	ORAL	375MG	Discontinued	not listed	No
002	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE	ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
003	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE	ORAL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
004	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE	ORAL	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
005	NIASPAN TITRATION STARTER PACK	NIACIN	TABLET, EXTENDED RELEASE	ORAL	375MG;500MG;750MG	Discontinued	not listed	No

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.