For major depressive disorder (MDD) with acute suicidal ideation or behavior in…. NDA 211243, held by Janssen Pharms. Esketamine Hydrochloride.
As of Nov 14, 2026, NDA 211243 (Spravato), held by Janssen Pharms, was first approved by FDA on Mar 5, 2019, with 18 approved supplements and 0 published complete response letters.
SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant
| Jan 17, 2025 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Jul 31, 2020 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 5, 2019 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SpravatoEQ 28MG BASE · spray;nasal | Esketamine Hydrochloride | RxReference drug |
| Sep 17, 2026 | Supplement 26Labeling · Standard review | Approved | |
| Jun 24, 2026 | Supplement 29REMS | Approved | |
| Apr 13, 2026 | Supplement 28REMS | Approved | |
| Jan 23, 2026 | Supplement 27REMS | Approved | |
| Oct 9, 2025 | Supplement 25REMS | Approved | |
| Jul 31, 2025 | Supplement 24REMS | Approved | |
| May 15, 2025 | Supplement 21REMS | Approved | |
| Apr 28, 2025 | Supplement 19Labeling · Standard review | Approved | |
| Mar 24, 2025 | Supplement 18REMS | Approved | |
| Jan 17, 2025 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Dec 31, 2024 | Supplement 13REMS | Approved | |
| Nov 4, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Oct 18, 2023 | Supplement 12Labeling | Approved | |
| Jan 3, 2022 | Supplement 6REMS | Approved | |
| Jul 31, 2020 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 11, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Jun 25, 2019 | Supplement 2REMS | Approved | |
| May 9, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Mar 5, 2019 | Original applicationNew active ingredient · 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
