ANDA 218854, held by Aurobindo Pharma Ltd. Pseudoephedrine Hydrochloride.
As of Nov 15, 2026, ANDA 218854 (Pseudoephedrine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Dec 29, 2025, with 0 approved supplements and 0 published complete response letters.
Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages relieves sinus pressure
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pseudoephedrine Hydrochloride240MG · tablet, extended release;oral | Pseudoephedrine Hydrochloride | OTC |
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
