Assyro AI

Orange Book product · Generic (ANDA)

METHADONE HYDROCHLORIDE INTENSOL

METHADONE HYDROCHLORIDE

Generic (ANDA)ANDA 089897TE AARX HIKMA

At a glance

Sep 06, 1988

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 06, 1988

    38 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METHADONE HYDROCHLORIDE

Strength

10MG/ML

Dosage form

CONCENTRATE

Route

ORAL

TE code

AA

Application

ANDA 089897

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METHADONE 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.