Assyro AI

Orange Book product · Generic (ANDA)

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

Generic (ANDA)ANDA 077471DISCN GENUS

At a glance

Dec 09, 2009

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 09, 2009

    16 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROMORPHONE HYDROCHLORIDE

Strength

2MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 077471

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROMORPHONE 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.