NDA 21714, held by Dr Reddys Labs Ltd. Amlodipine Maleate; Benazepril Hydrochloride.
As of Nov 14, 2026, NDA 21714 (Amlodipine Maleate; Benazepril Hydrochloride), held by Dr Reddys Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2006 | Original applicationNew combination · Standard review | Tentative approval | None posted |
| Amlodipine Maleate; Benazepril Hydrochloride2.5MG; 10MG · capsule; oral | Amlodipine Maleate; Benazepril Hydrochloride | None (tentative approval) |
| Amlodipine Maleate; Benazepril Hydrochloride5MG; 10MG · capsule; oral | Amlodipine Maleate; Benazepril Hydrochloride | None (tentative approval) |
| Amlodipine Maleate; Benazepril Hydrochloride5MG; 20MG · capsule; oral | Amlodipine Maleate; Benazepril Hydrochloride | None (tentative approval) |
| Amlodipine Maleate; Benazepril Hydrochloride10MG; 20MG · capsule; oral | Amlodipine Maleate; Benazepril Hydrochloride | None (tentative approval) |
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
