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FDA NDA · NDA211243

SPRAVATO

esketamine hydrochloride

Sponsor: JANSSEN PHARMS

APPLICATION
NDA211243
TYPE
NDA
ORIGINAL APPROVAL
2019-03-05
LATEST ACTION
2026-06-24
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

SPRAVATO · ReferencePrescription
ESKETAMINE HYDROCHLORIDE EQ 28MG BASE · SPRAY · NASAL

Approval history

2026-06-24REMS · Supplement 29 — Letter ↗AP
2026-04-13REMS · Supplement 28 — Letter ↗AP
2026-01-23REMS · Supplement 27 — Letter ↗AP
2025-10-09REMS · Supplement 25 — Letter ↗AP
2025-07-31REMS · Supplement 24 — Letter ↗AP
2025-05-15REMS · Supplement 21 — Letter ↗AP
2025-04-28Labeling · Supplement 19 · standard — Label ↗AP
2025-03-24REMS · Supplement 18 — Letter ↗AP
2025-01-17Efficacy · Supplement 16 · priority — Label ↗AP
2024-12-31REMS · Supplement 13 — Letter ↗AP
2024-11-04Labeling · Supplement 15 · standard — Label ↗AP
2023-10-18Labeling · Supplement 12 · 901 required — Letter ↗AP
2022-01-03REMS · Supplement 6 — Letter ↗AP
2020-07-31Efficacy · Supplement 4 · standard — Letter ↗AP
2020-02-11Labeling · Supplement 3 · standard — Letter ↗AP
2019-06-25REMS · Supplement 2 — Letter ↗AP
2019-05-09Labeling · Supplement 1 · standard — Label ↗AP
2019-03-05Type 2 - New Active Ingredient · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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