← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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