NDA 18050, held by Ucb Inc. Chlorpheniramine Polistirex; Phenylpropanolamine Polistirex.
As of Nov 14, 2026, NDA 18050 (Corsym), held by Ucb Inc, was first approved by FDA on Jan 4, 1984, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 1984 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CorsymEQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML · suspension, extended release;oral | Chlorpheniramine Polistirex; Phenylpropanolamine Polistirex | Discontinued |
| Apr 15, 1988 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 8, 1987 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1987 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1986 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1985 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1985 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1984 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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