U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 211951

NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE)
4MG/SPRAY
Marketing Status: Over-the-counter
Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NALOXONE HYDROCHLORIDE
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 4MG/SPRAY
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211951
Product Number: 001
Approval Date: Jun 21, 2022
Applicant Holder Full Name: PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
Back to Top