ANDA 77080, held by Synthon Pharms. Amlodipine Besylate.
As of Nov 15, 2026, ANDA 77080 (Amlodipine Besylate), held by Synthon Pharms, was first approved by FDA on Jun 27, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2007 | Original application | Approved | None posted |
| Amlodipine BesylateEQ 2.5MG BASE · tablet;oral | Amlodipine Besylate | Discontinued |
| Amlodipine BesylateEQ 5MG BASE · tablet;oral | Amlodipine Besylate | Discontinued |
| Amlodipine BesylateEQ 10MG BASE · tablet;oral | Amlodipine Besylate | Discontinued |
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
