← FDA Drug Approvals (Drugs@FDA)

SOLRIAMFETOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM LABORATORIES LTD · Approved 2026-09-29

Drug application

FDA Application #

ANDA218761

Application type

Abbreviated New Drug Application (Generic)

Brand name

SOLRIAMFETOL

Generic name

Solriamfetol

Active ingredients

SOLRIAMFETOL

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

UNICHEM LABORATORIES LTD

First approval

2026-09-29

Source

Authoritative

Drugs@FDA application overview

Machine

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