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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211243
Company: JANSSEN PHARMS

Medication Guide

REMS

Products on NDA 211243

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPRAVATO	ESKETAMINE HYDROCHLORIDE	EQ 28MG BASE	SPRAY;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211243

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2019	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211243Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2026	SUPPL-27	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211243Orig1s027ltr.pdf
10/09/2025	SUPPL-25	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s025ltr.pdf
07/31/2025	SUPPL-24	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s024ltr.pdf
05/15/2025	SUPPL-21	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s021ltr.pdf
04/28/2025	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s019ltr.pdf
03/24/2025	SUPPL-18	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s018ltr.pdf
01/17/2025	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s016ltr.pdf
11/04/2024	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211243s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211243Origs015ltr.pdf
12/31/2024	SUPPL-13	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211243Orig1s013ltr.pdf
10/18/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211243s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211243Orig1s012ltr.pdf
01/03/2022	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211243Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/211243Orig1s006.pdf
07/31/2020	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211243Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/211243Orig1s004.pdf
02/11/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211243Orig1s003ltr.pdf
06/25/2019	SUPPL-2	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211243Orig1s002ltr.pdf
05/09/2019	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211243Orig1s001ltr.pdf

Labels for NDA 211243

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2025	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s019lbl.pdf
01/17/2025	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s016lbl.pdf
11/04/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211243s015lbl.pdf
10/18/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211243s012lbl.pdf
07/31/2020	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf
02/11/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf
05/09/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243s001lbl.pdf
03/05/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243lbl.pdf

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