ANDA 209008, held by Aurobindo Pharma. Pseudoephedrine Hydrochloride.
As of Nov 15, 2026, ANDA 209008 (Pseudoephedrine Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Jun 9, 2017, 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 temporarily relieves sinus congestion and pressure
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pseudoephedrine Hydrochloride120MG · 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
