Details for New Drug Application (NDA): 204063
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The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 204063
Tradename: | TECFIDERA |
Applicant: | Biogen Inc |
Ingredient: | dimethyl fumarate |
Patents: | 9 |
Medical Subject Heading (MeSH) Categories for 204063
Suppliers and Packaging for NDA: 204063
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-005 | 64406-005-01 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) / 14 CAPSULE in 1 BOTTLE, PLASTIC |
TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-006 | 64406-006-02 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-006-02) / 60 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Mar 27, 2013 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 16, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING MULTIPLE SCLEROSIS |
Expired US Patents for NDA 204063
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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