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 078400

Expand all

BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE)
1MG/ML
Marketing Status: Prescription
Active Ingredient: BUTORPHANOL TARTRATE
Proprietary Name: BUTORPHANOL TARTRATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078400
Product Number: 001
Approval Date: May 1, 2009
Applicant Holder Full Name: HIKMA FARMACEUTICA (PORTUGAL) SA
Marketing Status:  Prescription
Patent and Exclusivity Information
BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE)
2MG/ML
Marketing Status: Prescription
Active Ingredient: BUTORPHANOL TARTRATE
Proprietary Name: BUTORPHANOL TARTRATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078400
Product Number: 002
Approval Date: May 1, 2009
Applicant Holder Full Name: HIKMA FARMACEUTICA (PORTUGAL) SA
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top