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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208411
Company: EMERGENT

Summary Review

Products on NDA 208411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NARCAN	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	Yes	Yes
NARCAN	NALOXONE HYDROCHLORIDE	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2015	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208411Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208411Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208411Orig1s007ltr.pdf
03/29/2023	SUPPL-6	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208411Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/208411Orig1s006TOC.cfm
08/06/2020	SUPPL-4	Manufacturing (CMC)-Expiration Date	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208411Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208411Orig1s004ltr.pdf
09/23/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208411Orig1s002lbl.pdf
01/24/2017	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208411s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208411Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/208411s001SumR.pdf

Labels for NDA 208411

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2023	SUPPL-6	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411Orig1s006lbl.pdf
03/27/2023	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411s007lbl.pdf
03/27/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208411s007lbl.pdf
08/06/2020	SUPPL-4	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208411Orig1s004lbl.pdf
09/23/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208411Orig1s002lbl.pdf
01/24/2017	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208411s001lbl.pdf
11/18/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

NARCAN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 4MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	217992	AMNEAL
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	211951	PADAGIS ISRAEL
NARCAN	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	208411	EMERGENT

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