Exalgo

NDA 21217, held by Specgx LLC. Hydromorphone Hydrochloride.

As of Nov 14, 2026, NDA 21217 (Exalgo), held by Specgx LLC, was first approved by FDA on Mar 1, 2010, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 1, 2010
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 1, 2010	Original applicationNew dosage form · Standard review	Approved	Other Summary Review Review Letter

Products

4 strengths and forms


Exalgo8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydromorphone Hydrochloride	DiscontinuedReference drug
Exalgo12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydromorphone Hydrochloride	DiscontinuedReference drug
Exalgo16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydromorphone Hydrochloride	DiscontinuedReference drug
Exalgo32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydromorphone Hydrochloride	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Oct 7, 2019	Supplement 25Labeling · Standard review	Approved	Label Medication Guide Letter
Sep 18, 2018	Supplement 23REMS	Approved	Label Letter
Sep 18, 2018	Supplement 24Labeling · Standard review	Approved	Label Letter
May 26, 2017	Supplement 21REMS	Approved	Letter
Dec 16, 2016	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 20REMS	Approved	Letter
Apr 20, 2016	Supplement 17REMS	Approved	Letter
Jun 26, 2015	Supplement 15REMS	Approved	Letter
Jun 2, 2015	Supplement 9Labeling · Standard review	Approved	Letter Label
Aug 19, 2014	Supplement 14REMS	Approved	Letter
Jun 17, 2014	Supplement 12Labeling · Standard review	Approved	Label Letter
Apr 16, 2014	Supplement 13Labeling	Approved	Letter Label
Apr 15, 2013	Supplement 6REMS	Approved	Letter
Mar 18, 2013	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 24, 2012	Supplement 4Labeling · Standard review	Approved	Label Letter
Jul 9, 2012	Supplement 2Labeling · Standard review	Approved	Label Letter
Mar 24, 2010	Supplement 1REMS	Approved	Letter
Mar 1, 2010	Original applicationNew dosage form · Standard review	Approved	Other Summary Review Review Letter

Identifiers

Application: NDA 21217
Drugs@FDA: Overview at FDA
Company: SpecGx

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