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 020067

Expand all

EC-NAPROSYN (NAPROXEN)
375MG
Marketing Status: Prescription
Active Ingredient: NAPROXEN
Proprietary Name: EC-NAPROSYN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 375MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020067
Product Number: 002
Approval Date: Oct 14, 1994
Applicant Holder Full Name: ATNAHS PHARMA US LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EC-NAPROSYN (NAPROXEN)
500MG
Marketing Status: Prescription
Active Ingredient: NAPROXEN
Proprietary Name: EC-NAPROSYN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020067
Product Number: 003
Approval Date: Oct 14, 1994
Applicant Holder Full Name: ATNAHS PHARMA US LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top