Assyro AI

Orange Book product · Generic (ANDA)

AMPHETAMINE SULFATE

AMPHETAMINE SULFATE

Generic (ANDA)ANDA 211139TE AARX AMNEAL PHARMS

At a glance

Sep 26, 2018

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 26, 2018

    7 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMPHETAMINE SULFATE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 211139

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMPHETAMINE 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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.