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 074978

IBUPROFEN (IBUPROFEN)
100MG/5ML
Marketing Status: Prescription
Active Ingredient: IBUPROFEN
Proprietary Name: IBUPROFEN
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A074978
Product Number: 001
Approval Date: Mar 25, 1998
Applicant Holder Full Name: ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top