Assyro AI

Orange Book product · Generic (ANDA)

PEMOLINE

PEMOLINE

Generic (ANDA)ANDA 075726DISCN MALLINCKRODT

At a glance

Mar 30, 2001

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 30, 2001

    25 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PEMOLINE

Strength

18.75MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 075726

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PEMOLINE

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.