Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204063

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TECFIDERA (DIMETHYL FUMARATE)
120MG Marketing Status: Prescription

Active Ingredient: DIMETHYL FUMARATE
Proprietary Name: TECFIDERA
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204063
Product Number: 001
Approval Date: Mar 27, 2013
Applicant Holder Full Name: BIOGEN IDEC INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TECFIDERA (DIMETHYL FUMARATE)
240MG Marketing Status: Prescription

Active Ingredient: DIMETHYL FUMARATE
Proprietary Name: TECFIDERA
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204063
Product Number: 002
Approval Date: Mar 27, 2013
Applicant Holder Full Name: BIOGEN IDEC INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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