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 022399

Expand all

HORIZANT (GABAPENTIN ENACARBIL)
300MG
Marketing Status: Prescription
Active Ingredient: GABAPENTIN ENACARBIL
Proprietary Name: HORIZANT
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022399
Product Number: 002
Approval Date: Dec 13, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HORIZANT (GABAPENTIN ENACARBIL)
600MG
Marketing Status: Prescription
Active Ingredient: GABAPENTIN ENACARBIL
Proprietary Name: HORIZANT
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022399
Product Number: 001
Approval Date: Apr 6, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top