CANASA — FDA application NDA021252

Application NDA021252 · type NDA · FDA status: approved · original approval 2001-01-05

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	CANASA	MESALAMINE	SUPPOSITORY	RECTAL	500MG	Discontinued	not listed	No
002	CANASA	MESALAMINE	SUPPOSITORY	RECTAL	1GM	Prescription	AB	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.

Listing	Product	Descriptive date	Flags/code
Patent 8217083	002	listed patent expiry date: 2028-06-06	drug product
Patent 8436051	002	listed patent expiry date: 2028-06-06	drug product

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

MESALAMINE · UNII 4Q81I59GXC · lmmol compound KBOPZPXVLCULAV-UHFFFAOYSA-N · CHEMBL704

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.