Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212865

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PREGABALIN (PREGABALIN)
50MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212865
Product Number: 001
Approval Date: Mar 20, 2020
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
75MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212865
Product Number: 002
Approval Date: Mar 20, 2020
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
100MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212865
Product Number: 003
Approval Date: Mar 20, 2020
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
150MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212865
Product Number: 004
Approval Date: Mar 20, 2020
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information