Assyro AI

Orange Book product · Brand (NDA)

DILAUDID-HP

HYDROMORPHONE HYDROCHLORIDE

Brand (NDA)NDA 019034DISCN FRESENIUS KABI USA

At a glance

Aug 04, 1994

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 04, 1994

    32 yr 4 mo ago

  2. Today

  3. Patent 9731082 expires

    Listed drug product patent expiration.

    Apr 23, 2032

    in 5 yr 11 mo

  4. Patent 9248229 expires

    Listed drug product patent expiration.

    Mar 12, 2034

    in 7 yr 10 mo

Pharmaceutical detail

Active ingredient

HYDROMORPHONE HYDROCHLORIDE

Strength

250MG/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019034

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9731082Apr 23, 2032in 5 yr 11 mo
Product
9248229Mar 12, 2034in 7 yr 10 mo
Product
Agent CTA Background

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