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DIMETHYL FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SHILPA MEDICARE LTD · Approved 2018-11-09

Drug application

FDA Application #
ANDA210291
Application type
Abbreviated New Drug Application (Generic)
Brand name
DIMETHYL FUMARATE
Generic name
Dimethyl Fumarate
Active ingredients
DIMETHYL FUMARATE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
SHILPA MEDICARE LTD
First approval
2018-11-09

Source

Authoritative
Drugs@FDA application overview
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