Assyro AI

Orange Book product · Generic (ANDA)

DEXAMETHASONE INTENSOL

DEXAMETHASONE

Generic (ANDA)ANDA 088252RX HIKMA

At a glance

Sep 01, 1983

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 01, 1983

    43 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXAMETHASONE

Strength

1MG/ML

Dosage form

CONCENTRATE

Route

ORAL

TE code

Not listed

Application

ANDA 088252

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DEXAMETHASONE

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.