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 202074

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 3MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 3MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202074
Product Number: 001
Approval Date: Mar 25, 2013
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top