← FDA Drug Approvals (Drugs@FDA)
MODAFINIL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2026-09-03
Drug application
- FDA Application #
ANDA208343- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MODAFINIL
- Generic name
- Modafinil
- Active ingredients
- MODAFINIL
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- LUPIN
- First approval
- 2026-09-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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