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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214697
Company: ARS PHARMS OPERATION

Products on NDA 214697

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEFFY	EPINEPHRINE	2MG/SPRAY	SPRAY;NASAL	Prescription	None	Yes	Yes
NEFFY	EPINEPHRINE	1MG/SPRAY	SPRAY;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214697

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214697s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214697Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214697Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2026	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214697Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214697Orig1s004ltr.pdf
10/24/2025	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214697Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214697Orig1s003ltr.pdf
03/26/2026	SUPPL-2	Efficacy-New Patient Population	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214697Orig1s002ltr.pdf
03/05/2025	SUPPL-1	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214697Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214697Orig1s001ltr.pdf

Labels for NDA 214697

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2026	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214697Orig1s004lbl.pdf
03/26/2026	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214697Orig1s004lbl.pdf
10/24/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214697Orig1s003lbl.pdf
10/24/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214697Orig1s003lbl.pdf
03/05/2025	SUPPL-1	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214697Orig1s001lbl.pdf
08/09/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214697s000lbl.pdf

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