Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208411

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NARCAN (NALOXONE HYDROCHLORIDE)
4MG/SPRAY
Marketing Status: Over-the-counter

Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NARCAN
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 4MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208411
Product Number: 001
Approval Date: Nov 18, 2015
Applicant Holder Full Name: EMERGENT OPERATIONS IRELAND LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

NARCAN (NALOXONE HYDROCHLORIDE)
2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NARCAN
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208411
Product Number: 002
Approval Date: Jan 24, 2017
Applicant Holder Full Name: EMERGENT OPERATIONS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information