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 022396

DYLOJECT (DICLOFENAC SODIUM)
37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: DYLOJECT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022396
Product Number: 001
Approval Date: Dec 23, 2014
Applicant Holder Full Name: JAVELIN PHARMACEUTICALS INC A WHOLLY OWNED SUDSIDIARY OF HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top