ANDA 219686, held by Teva Pharms Inc. Amlodipine Besylate.
As of Nov 15, 2026, ANDA 219686 (Amlodipine Besylate), held by Teva Pharms Inc, was first approved by FDA on Jan 22, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2026 | 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
