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 203543

AMMONIA N 13 (AMMONIA N-13)
3.75mCi-260mCi/ML
Marketing Status: Prescription
Active Ingredient: AMMONIA N-13
Proprietary Name: AMMONIA N 13
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 3.75mCi-260mCi/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A203543
Product Number: 001
Approval Date: Dec 14, 2012
Applicant Holder Full Name: SOFIE CO DBA SOFIE
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top