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LISDEXAMFETAMINE DIMESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2024-12-16

Drug application

FDA Application #

ANDA219258

Application type

Abbreviated New Drug Application (Generic)

Brand name

LISDEXAMFETAMINE DIMESYLATE

Generic name

LISDEXAMFETAMINE DIMESYLATE

Active ingredients

LISDEXAMFETAMINE DIMESYLATE

Dosage form

TABLET, CHEWABLE

Route

ORAL

Marketing status

Prescription

Sponsor

GRANULES

Manufacturer

Granules Pharmaceuticals Inc.

First approval

2024-12-16

Source

Authoritative

Drugs@FDA application overview

Machine

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