Product Details for ANDA 210480
LENALIDOMIDE (LENALIDOMIDE)
2.5MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
15MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
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: A210480
Product Number: 005
Approval Date: Mar 6, 2023
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
LENALIDOMIDE (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: A210480
Product Number: 005
Approval Date: Mar 6, 2023
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210480
Product Number: 001
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
LENALIDOMIDE (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: A210480
Product Number: 001
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210480
Product Number: 002
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
LENALIDOMIDE (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: A210480
Product Number: 002
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210480
Product Number: 003
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
LENALIDOMIDE (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: A210480
Product Number: 003
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210480
Product Number: 006
Approval Date: Mar 6, 2023
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
LENALIDOMIDE (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: A210480
Product Number: 006
Approval Date: Mar 6, 2023
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210480
Product Number: 004
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LENALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210480
Product Number: 004
Approval Date: Aug 31, 2022
Applicant Holder Full Name: LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
Marketing Status: Prescription
Patent and Exclusivity Information