Assyro AI

Orange Book product · Brand (NDA)

ADDERALL XR 25

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand (NDA)NDA 021303TE AB1RX TAKEDA PHARMS USA
View AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE familyOpen on FDA Orange Book

At a glance

May 22, 2002

Approved

Brand (NDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 22, 2002

    24 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB1

Application

NDA 021303

Product number

004

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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