Palladone

NDA 21044, held by Purdue Pharma LP. Hydromorphone Hydrochloride.

As of Nov 14, 2026, NDA 21044 (Palladone), held by Purdue Pharma LP, was first approved by FDA on Sep 24, 2004, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 24, 2004
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 24, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Palladone12MG · capsule, extended release;oral	Hydromorphone Hydrochloride	Discontinued
Palladone16MG · capsule, extended release;oral	Hydromorphone Hydrochloride	Discontinued
Palladone24MG · capsule, extended release;oral	Hydromorphone Hydrochloride	Discontinued
Palladone32MG · capsule, extended release;oral	Hydromorphone Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 16, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 24, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21044
Drugs@FDA: Overview at FDA
Company: Purdue Pharma

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