Treats hypertension. ANDA 216606, held by Amta. Nisoldipine.
As of Nov 15, 2026, ANDA 216606 (Nisoldipine), held by Amta, was first approved by FDA on Apr 10, 2023, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Nisoldipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 10, 2023 | Original application | Approved | None posted |
| Nisoldipine8.5MG · tablet, extended release;oral | Nisoldipine | Rx |
| Nisoldipine17MG · tablet, extended release;oral | Nisoldipine | Rx |
| Dec 12, 2025 | Supplement 2Manufacturing | Approved | None posted |
| Apr 10, 2023 | Original application | Approved | None posted |
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
