Dilaudid

Manages pain severe enough to require an opioid analgesic. NDA 19891, held by Rhodes Pharms. Hydromorphone Hydrochloride.

As of Nov 13, 2026, NDA 19891 (Dilaudid), held by Rhodes Pharms, was first approved by FDA on Dec 7, 1992, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 7, 1992
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Dec 7, 1992	Original applicationNew dosage form · Standard review	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dilaudid5MG/5ML · solution;oral	Hydromorphone Hydrochloride	RxReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 18, 2026	Supplement 35REMS	Approved	Letter
Dec 22, 2025	Supplement 34Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 33REMS	Approved	Letter
Dec 15, 2023	Supplement 31Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 4, 2021	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 28Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 27Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 26REMS	Approved	Letter Label
Dec 16, 2016	Supplement 24Labeling · Standard review	Approved	Label Letter
Feb 12, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 12, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 5, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 9, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 16, 2015	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 14, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 12, 2006	Supplement 8Labeling · Standard review	Approved	Label Letter
Mar 10, 2003	Supplement 2Labeling · Standard review	Approved	None posted
Aug 22, 2001	Supplement 4Labeling · Standard review	Approved	None posted
Nov 24, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 31, 1995	Supplement 1Labeling · Standard review	Approved	None posted
Dec 7, 1992	Original applicationNew dosage form · Standard review	Approved	REMS

Identifiers

Application: NDA 19891
Drugs@FDA: Overview at FDA
Company: Rhodes Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters