ACUVAIL — FDA application NDA022427

Application NDA022427 · type NDA · FDA status: approved · original approval 2009-07-22

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	ACUVAIL	KETOROLAC TROMETHAMINE	SOLUTION/DROPS	OPHTHALMIC	0.45%	Prescription	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.

Listing	Product	Descriptive date	Flags/code
Patent 8512717	001	listed patent expiry date: 2028-03-07	drug product
Patent 9192571	001	listed patent expiry date: 2028-03-07	drug product
Patent 7842714	001	listed patent expiry date: 2029-08-15	drug substance, 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.

KETOROLAC TROMETHAMINE · UNII 4EVE5946BQ · lmmol compound BWHLPLXXIDYSNW-UHFFFAOYSA-N · CHEMBL1201124

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.