Last Updated: November 8, 2026

Details for New Drug Application (NDA): 021217

NDA 021217 describes EXALGO, which is a drug marketed by Specgx Llc and is included in one NDA. Additional details are available on the EXALGO profile page.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for 021217

Tradename:	EXALGO
Applicant:	Specgx Llc
Ingredient:	hydromorphone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 021217

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 1, 2010	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 1, 2010	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 1, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 021217

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010	5,914,131	⤷ Start Trial
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012	5,914,131	⤷ Start Trial
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010	5,702,725	⤷ Start Trial
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010	5,702,725	⤷ Start Trial
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012	5,702,725	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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