ANDA 77362, held by Genpharm. Amlodipine Besylate.
As of Nov 15, 2026, ANDA 77362 (Amlodipine Besylate), held by Genpharm, was first approved by FDA on Jul 9, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 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
