← FDA Drug Approvals (Drugs@FDA)

AMPHETAMINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES PHARMACEUTICALS INC · Approved 2026-01-07

Drug application

FDA Application #

ANDA220284

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMPHETAMINE

Generic name

Amphetamine

Active ingredients

AMPHETAMINE

Dosage form

TABLET, EXTENDED RELEASE

Route

—

Marketing status

None (Tentative Approval)

Sponsor

GRANULES PHARMACEUTICALS INC

First approval

2026-01-07

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown