Assyro AI

Orange Book product · Generic (ANDA)

METHYLPHENIDATE

METHYLPHENIDATE

Generic (ANDA)ANDA 206497TE ABRX MYLAN TECH VIATRIS

At a glance

Mar 14, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 14, 2022

    4 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METHYLPHENIDATE

Strength

10MG/9HR (1.1MG/HR)

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

AB

Application

ANDA 206497

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METHYLPHENIDATE

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.