Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215755

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PREGABALIN (PREGABALIN)
25MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215755
Product Number: 001
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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: A215755
Product Number: 002
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
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: A215755
Product Number: 003
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
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: A215755
Product Number: 004
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
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: A215755
Product Number: 005
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
200MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215755
Product Number: 006
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
225MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 225MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215755
Product Number: 007
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PREGABALIN (PREGABALIN)
300MG
Marketing Status: Prescription

Active Ingredient: PREGABALIN
Proprietary Name: PREGABALIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215755
Product Number: 008
Approval Date: Apr 26, 2023
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information