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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
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