ANDA 210489, held by Ipca Labs Ltd. Amlodipine Besylate.
As of Nov 15, 2026, ANDA 210489 (Amlodipine Besylate), held by Ipca Labs Ltd, was first approved by FDA on Sep 22, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2026 | Original application | Approved | None posted |
| Amlodipine BesylateEQ 2.5MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Amlodipine BesylateEQ 5MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Amlodipine BesylateEQ 10MG BASE · tablet;oral | Amlodipine Besylate | Rx |
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
