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Active Ingredient: ESZOPICLONE
Proprietary Name: ESZOPICLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205504
Product Number: 001
Approval Date: Jan 4, 2024
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:
Prescription
Patent and Exclusivity Information
Active Ingredient: ESZOPICLONE
Proprietary Name: ESZOPICLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205504
Product Number: 002
Approval Date: Jan 4, 2024
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:
Prescription
Patent and Exclusivity Information
Active Ingredient: ESZOPICLONE
Proprietary Name: ESZOPICLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205504
Product Number: 003
Approval Date: Jan 4, 2024
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:
Prescription
Patent and Exclusivity Information