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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021044

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NDA 021044 describes PALLADONE, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. Additional details are available on the PALLADONE profile page.

The generic ingredient in PALLADONE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for 021044

Tradename:	PALLADONE
Applicant:	Purdue Pharma Lp
Ingredient:	hydromorphone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 021044

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	12MG
Approval Date:	Sep 24, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	16MG
Approval Date:	Sep 24, 2004	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	24MG
Approval Date:	Sep 24, 2004	TE:		RLD:	No

Expired US Patents for NDA 021044

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	5,968,551	⤷ Get Started Free
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	5,958,452	⤷ Get Started Free
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	6,706,281	⤷ Get Started Free
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	6,335,033	⤷ Get Started Free
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004	6,706,281	⤷ Get Started Free
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004	6,294,195	⤷ Get Started Free
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	5,958,452	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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