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 078989

Expand all

ZALEPLON (ZALEPLON)
5MG
Marketing Status: Prescription
Active Ingredient: ZALEPLON
Proprietary Name: ZALEPLON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078989
Product Number: 001
Approval Date: Jun 6, 2008
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ZALEPLON (ZALEPLON)
10MG
Marketing Status: Prescription
Active Ingredient: ZALEPLON
Proprietary Name: ZALEPLON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078989
Product Number: 002
Approval Date: Jun 6, 2008
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top