Orange Book product · Brand (NDA)

DILAUDID

HYDROMORPHONE HYDROCHLORIDE

Brand (NDA)NDA 019034TE APRX FRESENIUS KABI USA

Jan 16, 2020

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 16, 2020
6 yr 6 mo ago
Today
Patent 9731082 expires
Listed drug product patent expiration.
Apr 23, 2032
in 5 yr 11 mo
Patent 9248229 expires
Listed drug product patent expiration.
Mar 12, 2034
in 7 yr 10 mo

Active ingredient

HYDROMORPHONE HYDROCHLORIDE

Strength

0.2MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Application

NDA 019034

Product number

006

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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