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

Supporting Documents

View All  (1)
Comments Not Accepted
Supporting & Related Material
Posted: 02/18/2005
ID: FDA-2005-P-0325-0001


View All  (3)

Comments Received*
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.