NDA 201656, held by Acerus Pharms. Desmopressin Acetate.
As of Nov 13, 2026, NDA 201656 (Noctiva), held by Acerus Pharms, was first approved by FDA on Mar 3, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Noctiva0.00083MG/SPRAY · spray, metered;nasal | Desmopressin Acetate | DiscontinuedReference drug |
| Noctiva0.00166MG/SPRAY · spray, metered;nasal | Desmopressin Acetate | DiscontinuedReference drug |
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
