For subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless…. NDA 203340, held by Azurity. Nimodipine.
As of Nov 13, 2026, NDA 203340 (Nymalize), held by Azurity, was first approved by FDA on May 10, 2013, with 7 approved supplements and 0 published complete response letters.
NYMALIZE is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2013 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nymalize3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Nimodipine | DiscontinuedReference drug |
| Nymalize6MG/ML · solution;oral | Nimodipine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2024 | Supplement 19Manufacturing | Approved | |
| Dec 18, 2020 | Supplement 13Manufacturing · Standard review | Approved | |
| Apr 9, 2020 | Supplement 11Manufacturing | Approved | |
| Dec 28, 2019 | Supplement 12Labeling · Standard review | Approved | |
| Mar 2, 2016 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 26, 2015 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 7, 2015 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| May 10, 2013 | Original applicationNew dosage form · Priority review | Approved |
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
