NDA 206030, held by Lundbeck Pharms LLC. Carbamazepine.
As of Nov 13, 2026, NDA 206030 (Carnexiv), held by Lundbeck Pharms LLC, was first approved by FDA on Oct 7, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carnexiv200MG/20ML (10MG/ML) · solution;intravenous | Carbamazepine | DiscontinuedReference drug |
| Dec 12, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Oct 7, 2016 | Original applicationNew dosage form · Standard 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
