U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  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 204852

Expand all

TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
50MG
Marketing Status: Prescription
Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204852
Product Number: 001
Approval Date: Feb 5, 2020
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
100MG
Marketing Status: Prescription
Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204852
Product Number: 002
Approval Date: Feb 5, 2020
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
150MG
Marketing Status: Prescription
Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204852
Product Number: 003
Approval Date: Feb 5, 2020
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
300MG
Marketing Status: Prescription
Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204852
Product Number: 004
Approval Date: Feb 5, 2020
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top