NDA 19672, held by Alza. Brompheniramine Maleate; Pseudoephedrine Hydrochloride.
As of Nov 13, 2026, NDA 19672 (Efidac 24 Pseudoephedrine Hydrochloride/Brompheniramine Maleate), held by Alza, was first approved by FDA on Mar 29, 1996, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efidac 24 Pseudoephedrine Hydrochloride/Brompheniramine Maleate16MG;240MG · tablet, extended release;oral | Brompheniramine Maleate; Pseudoephedrine 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
