Product Details for ANDA 091113
ESZOPICLONE (ESZOPICLONE)
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
3MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
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: A091113
Product Number: 001
Approval Date: Jun 10, 2014
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ESZOPICLONE (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: A091113
Product Number: 001
Approval Date: Jun 10, 2014
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
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: A091113
Product Number: 002
Approval Date: Jun 10, 2014
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ESZOPICLONE (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: A091113
Product Number: 002
Approval Date: Jun 10, 2014
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
3MG
Marketing Status: Prescription
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: A091113
Product Number: 003
Approval Date: Jun 10, 2014
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ESZOPICLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091113
Product Number: 003
Approval Date: Jun 10, 2014
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information