NDA 22556, held by Aytu. Carbinoxamine Maleate.
As of Nov 14, 2026, NDA 22556 (Karbinal Er), held by Aytu, was first approved by FDA on Mar 28, 2013, with 5 approved supplements and 0 published complete response letters.
Carbinoxamine Maleate extended-release oral suspension is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled Amelioration of the severity of allergic reactions to blood or plasma
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2013 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Karbinal Er4MG/5ML · suspension, extended release;oral | Carbinoxamine Maleate | RxReference drug |
| Mar 10, 2026 | Supplement 15Labeling · Standard review | Approved | |
| Mar 25, 2021 | Supplement 6Labeling · Standard review | Approved | |
| May 12, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 2, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 28, 2013 | Original applicationNew dosage form · Standard review | Approved |
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
