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 213561

ATROPINE SULFATE (ATROPINE SULFATE)
8MG/20ML (0.4MG/ML)
Marketing Status: Prescription
Active Ingredient: ATROPINE SULFATE
Proprietary Name: ATROPINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
Strength: 8MG/20ML (0.4MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213561
Product Number: 001
Approval Date: Dec 1, 2021
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top