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 NDA 215457

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) (NALOXONE HYDROCHLORIDE)
10MG/0.4ML (10MG/0.4ML)
Marketing Status: Discontinued
Active Ingredient: NALOXONE HYDROCHLORIDE
Proprietary Name: NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: 10MG/0.4ML (10MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215457
Product Number: 001
Approval Date: Feb 28, 2022
Applicant Holder Full Name: KALEO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top