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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. There is one patent protecting this drug. Additional details are available on the PALLADONE profile page.

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

Summary for NDA: 021044

Tradename:
PALLADONE
Applicant:
Purdue Pharma Lp
Ingredient:
hydromorphone hydrochloride
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Sep 24, 2004TE:RLD:No
Patent:6,589,960Patent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Sep 24, 2004TE:RLD:No
Patent:6,589,960Patent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength24MG
Approval Date:Sep 24, 2004TE:RLD:No
Patent:6,589,960Patent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book 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;ORAL021044-002Sep 24, 20045,968,551► subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-001Sep 24, 20046,743,442► subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-004Sep 24, 20046,743,442► subscribe
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