NDA 18794, held by Graham Dm. Chlorpheniramine Maleate; Phenylpropanolamine Hydrochloride.
As of Nov 13, 2026, NDA 18794 (Cold Capsule V), held by Graham Dm, was first approved by FDA on Apr 23, 1985, with 1 approved supplement and 0 published complete response letters.
| Jun 25, 1997 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Apr 23, 1985 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cold Capsule V8MG;75MG · capsule, extended release;oral | Chlorpheniramine Maleate; Phenylpropanolamine Hydrochloride | Discontinued |
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
