Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205437

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OTEZLA (APREMILAST)
10MG Marketing Status: Prescription

Active Ingredient: APREMILAST
Proprietary Name: OTEZLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205437
Product Number: 001
Approval Date: Mar 21, 2014
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

OTEZLA (APREMILAST)
20MG Marketing Status: Prescription

Active Ingredient: APREMILAST
Proprietary Name: OTEZLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205437
Product Number: 002
Approval Date: Mar 21, 2014
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

OTEZLA (APREMILAST)
30MG Marketing Status: Prescription

Active Ingredient: APREMILAST
Proprietary Name: OTEZLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205437
Product Number: 003
Approval Date: Mar 21, 2014
Applicant Holder Full Name: CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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