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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210531

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DIMETHYL FUMARATE (DIMETHYL FUMARATE)
120MG
Marketing Status: Prescription
Active Ingredient: DIMETHYL FUMARATE
Proprietary Name: DIMETHYL FUMARATE
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210531
Product Number: 001
Approval Date: Aug 17, 2020
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DIMETHYL FUMARATE (DIMETHYL FUMARATE)
240MG
Marketing Status: Prescription
Active Ingredient: DIMETHYL FUMARATE
Proprietary Name: DIMETHYL FUMARATE
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210531
Product Number: 002
Approval Date: Aug 17, 2020
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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