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Orange Book product · Generic (ANDA)

AMPHETAMINE SULFATE

AMPHETAMINE SULFATE

Generic (ANDA)ANDA 213720TE AARX ALKEM LABS LTD
View AMPHETAMINE SULFATE familyOpen on FDA Orange Book

At a glance

Oct 27, 2020

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 27, 2020

    5 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMPHETAMINE SULFATE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 213720

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

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