Temporary Recall of Approval of OxyContin and Palladone Removal From Market and Label Changes Limiting Indications to Severe Chronic Pain From Documented Peripheral Tissue Disease Potential - CLOSED

 
Docket ID: FDA-2005-P-0325
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
Keyword(s): painkillers, morphine, oxycodone, Barbara Van Rooyan, Kirk Van Rooyan, cancer, back pain, chronic pain, palladone, OxyContin, CDER, closed
Legacy ID: 2005P-0076
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (10)
Comment Period Closed
Other
Posted: 09/10/2013
ID: FDA-2005-P-0325-0014
Comment Period Closed
Other
Posted: 12/22/2008
ID: FDA-2005-P-0325-0007
Comment Period Closed
Other
Posted: 12/22/2008
ID: FDA-2005-P-0325-0009
Comment Period Closed
Other
Posted: 12/22/2008
ID: FDA-2005-P-0325-0010
Comment Period Closed
Other
Posted: 12/22/2008
ID: FDA-2005-P-0325-0008

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 02/18/2005
ID: FDA-2005-P-0325-0001

Comments

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8
Comments Received*
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