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 203438

MONTELUKAST SODIUM (MONTELUKAST SODIUM)
EQ 4MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: MONTELUKAST SODIUM
Proprietary Name: MONTELUKAST SODIUM
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 4MG BASE/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203438
Product Number: 001
Approval Date: Jul 31, 2015
Applicant Holder Full Name: AJANTA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top