Product Details for ANDA 211687
PREGABALIN (PREGABALIN)
82.5MG
Marketing Status: Discontinued
165MG
Marketing Status: Discontinued
330MG
Marketing Status: Discontinued
82.5MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 82.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211687
Product Number: 001
Approval Date: Jul 6, 2021
Applicant Holder Full Name: ALVOGEN MALTA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 82.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211687
Product Number: 001
Approval Date: Jul 6, 2021
Applicant Holder Full Name: ALVOGEN MALTA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
165MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 165MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211687
Product Number: 002
Approval Date: Jul 6, 2021
Applicant Holder Full Name: ALVOGEN MALTA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PREGABALIN (PREGABALIN)
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 165MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211687
Product Number: 002
Approval Date: Jul 6, 2021
Applicant Holder Full Name: ALVOGEN MALTA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
330MG
Marketing Status: Discontinued
Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 330MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211687
Product Number: 003
Approval Date: Jul 6, 2021
Applicant Holder Full Name: ALVOGEN MALTA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 330MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211687
Product Number: 003
Approval Date: Jul 6, 2021
Applicant Holder Full Name: ALVOGEN MALTA OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information