NDA 21435, held by Dr Reddys Labs Inc. Amlodipine Maleate.
As of Nov 14, 2026, NDA 21435 (Amvaz), held by Dr Reddys Labs Inc, was first approved by FDA on Oct 31, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2003 | Original applicationNew active ingredient · Standard review | Approved |
| Amvaz2.5MG · tablet;oral | Amlodipine Maleate | Discontinued |
| Amvaz5MG · tablet;oral | Amlodipine Maleate | Discontinued |
| Amvaz10MG · tablet;oral | Amlodipine Maleate | 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
