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 215320

COMBOGESIC IV (ACETAMINOPHEN; IBUPROFEN SODIUM)
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; IBUPROFEN SODIUM
Proprietary Name: COMBOGESIC IV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215320
Product Number: 001
Approval Date: Oct 17, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top