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 007961

BENTYL (DICYCLOMINE HYDROCHLORIDE)
10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DICYCLOMINE HYDROCHLORIDE
Proprietary Name: BENTYL
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N007961
Product Number: 002
Approval Date: Oct 15, 1984
Applicant Holder Full Name: APTALIS PHARMA US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top