← FDA Drug Approvals (Drugs@FDA)
DIMETHYL FUMARATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2020-09-24
Drug application
- FDA Application #
ANDA210440- 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
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2020-09-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown