Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212045

KLOXXADO (NALOXONE HYDROCHLORIDE)
8MG/SPRAY
Marketing Status: Prescription
Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: KLOXXADO
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 8MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212045
Product Number: 001
Approval Date: Apr 29, 2021
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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