Manages moderately severe. ANDA 204054, held by Lgm Pharma. Mecamylamine Hydrochloride.
As of Nov 15, 2026, ANDA 204054 (Mecamylamine Hydrochloride), held by Lgm Pharma, was first approved by FDA on Mar 19, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mecamylamine Hydrochloride2.5MG · tablet;oral | Mecamylamine Hydrochloride | Rx |
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
