Assyro AI

Orange Book product · Generic (ANDA)

GLUTETHIMIDE

GLUTETHIMIDE

Generic (ANDA)ANDA 089458DISCN HALSEY

At a glance

Oct 10, 1986

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 10, 1986

    40 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GLUTETHIMIDE

Strength

250MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 089458

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GLUTETHIMIDE

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.