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Orange Book product · Generic (ANDA)

TIOPRONIN

TIOPRONIN

Generic (ANDA)ANDA 216198DISCN PH HEALTH

At a glance

Jun 02, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 02, 2022

    4 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIOPRONIN

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 216198

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TIOPRONIN

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.