NDA 208582, held by Altaire Pharms Inc. Benoxinate Hydrochloride; Fluorescein Sodium.
As of Nov 14, 2026, NDA 208582 (Altafluor Benox), held by Altaire Pharms Inc, was first approved by FDA on Dec 14, 2017, with 0 approved supplements and 0 published complete response letters.
Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a combination disclosing agent and local ester anesthetic indicated for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 14, 2017 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Altafluor Benox0.4%;0.25% · solution/drops;ophthalmic | Benoxinate Hydrochloride; Fluorescein Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
