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Orange Book product · Generic (ANDA)

DEXTROAMPHETAMINE SULFATE

DEXTROAMPHETAMINE SULFATE

Generic (ANDA)ANDA 203644TE AARX TRIS PHARMA INC
View DEXTROAMPHETAMINE SULFATE familyOpen on FDA Orange Book

At a glance

May 29, 2013

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 29, 2013

    13 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXTROAMPHETAMINE SULFATE

Strength

5MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 203644

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DEXTROAMPHETAMINE SULFATE

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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