Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217265

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LENALIDOMIDE (LENALIDOMIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: LENALIDOMIDE
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217265
Product Number: 001
Approval Date: Feb 22, 2024
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LENALIDOMIDE (LENALIDOMIDE)
5MG
Marketing Status: Prescription

Active Ingredient: LENALIDOMIDE
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217265
Product Number: 002
Approval Date: Feb 22, 2024
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LENALIDOMIDE (LENALIDOMIDE)
10MG
Marketing Status: Prescription

Active Ingredient: LENALIDOMIDE
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217265
Product Number: 003
Approval Date: Feb 22, 2024
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LENALIDOMIDE (LENALIDOMIDE)
15MG
Marketing Status: Prescription

Active Ingredient: LENALIDOMIDE
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217265
Product Number: 004
Approval Date: Feb 22, 2024
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LENALIDOMIDE (LENALIDOMIDE)
20MG
Marketing Status: Prescription

Active Ingredient: LENALIDOMIDE
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217265
Product Number: 005
Approval Date: Feb 22, 2024
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LENALIDOMIDE (LENALIDOMIDE)
25MG
Marketing Status: Prescription

Active Ingredient: LENALIDOMIDE
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217265
Product Number: 006
Approval Date: Feb 22, 2024
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information