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 216081

Expand all

GADOBUTROL (GADOBUTROL)
18.1416GM/30ML (604.72MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOBUTROL
Proprietary Name: GADOBUTROL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 18.1416GM/30ML (604.72MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216081
Product Number: 001
Approval Date: Sep 8, 2023
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
GADOBUTROL (GADOBUTROL)
39.3068GM/65ML (604.72MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOBUTROL
Proprietary Name: GADOBUTROL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 39.3068GM/65ML (604.72MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216081
Product Number: 002
Approval Date: Sep 8, 2023
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top