Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211593

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PREGABALIN (PREGABALIN)
82.5MG
Marketing Status: Prescription

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: AB
Application Number: A211593
Product Number: 001
Approval Date: Apr 13, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
165MG
Marketing Status: Prescription

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: AB
Application Number: A211593
Product Number: 002
Approval Date: Apr 13, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
330MG
Marketing Status: Prescription

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: AB
Application Number: A211593
Product Number: 003
Approval Date: Apr 13, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information