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FDA NDA · NDA021044

PALLADONE

Sponsor: PURDUE PHARMA LP

APPLICATION
NDA021044
TYPE
NDA
ORIGINAL APPROVAL
2004-09-24
LATEST ACTION
2014-04-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PALLADONEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 32MG · CAPSULE, EXTENDED RELEASE · ORAL
PALLADONEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 16MG · CAPSULE, EXTENDED RELEASE · ORAL
PALLADONEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 24MG · CAPSULE, EXTENDED RELEASE · ORAL
PALLADONEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 12MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2014-04-16Labeling · Supplement 13 · standard — Label ↗AP
2004-09-24Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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