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Orange Book product · Generic (ANDA)

DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE

Generic (ANDA)ANDA 209754DISCN BIONPHARMA
View DEXMETHYLPHENIDATE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Mar 24, 2020

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 24, 2020

    6 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 209754

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DEXMETHYLPHENIDATE HYDROCHLORIDE

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.

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