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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021880

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REVLIMID (LENALIDOMIDE)
2.5MG
Marketing Status: Prescription
Active Ingredient: LENALIDOMIDE
Proprietary Name: REVLIMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021880
Product Number: 005
Approval Date: Dec 21, 2011
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
REVLIMID (LENALIDOMIDE)
5MG
Marketing Status: Prescription
Active Ingredient: LENALIDOMIDE
Proprietary Name: REVLIMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021880
Product Number: 001
Approval Date: Dec 27, 2005
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
REVLIMID (LENALIDOMIDE)
10MG
Marketing Status: Prescription
Active Ingredient: LENALIDOMIDE
Proprietary Name: REVLIMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021880
Product Number: 002
Approval Date: Dec 27, 2005
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
REVLIMID (LENALIDOMIDE)
15MG
Marketing Status: Prescription
Active Ingredient: LENALIDOMIDE
Proprietary Name: REVLIMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021880
Product Number: 003
Approval Date: Jun 29, 2006
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
REVLIMID (LENALIDOMIDE)
20MG
Marketing Status: Prescription
Active Ingredient: LENALIDOMIDE
Proprietary Name: REVLIMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021880
Product Number: 006
Approval Date: Jun 5, 2013
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
REVLIMID (LENALIDOMIDE)
25MG
Marketing Status: Prescription
Active Ingredient: LENALIDOMIDE
Proprietary Name: REVLIMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021880
Product Number: 004
Approval Date: Jun 29, 2006
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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