NDA 22026, held by Synthon Pharms. Amlodipine Besylate.
As of Nov 14, 2026, NDA 22026 (Amlodipine Besylate), held by Synthon Pharms, was first approved by FDA on Sep 27, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Amlodipine BesylateEQ 2.5MG BASE · tablet, orally disintegrating;oral | Amlodipine Besylate | DiscontinuedReference drug |
| Amlodipine BesylateEQ 5MG BASE · tablet, orally disintegrating;oral | Amlodipine Besylate | DiscontinuedReference drug |
| Amlodipine BesylateEQ 10MG BASE · tablet, orally disintegrating;oral | Amlodipine Besylate | DiscontinuedReference drug |
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
