Determine that Oxycodone Hydrochloride Extended Release Tablets, 10mg, 15mg, 20mg, 30mg, 40mg, 60 mg, and 80mg, of Perdue Pharma LP, Were Voluntarily Withdrawn for Reasons Other Than Safety or Effectiveness - CLOSED

 
Docket ID: FDA-2010-P-0540
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Title: Extended Release Tablets, 10mg, 15mg, 20mg, 30mg, 40mg, 60 mg, and 80mg, of Perdue Pharma LP, Were Voluntarily Withdrawn for Reasons Other Than Safety or Effectiveness
Keyword(s): CDER, Oxycodone Hydrochloride , extended release tablets, 15 mg, 20 mg, 40 mg, 60 mg, 80 mg, Sherppard Mullin Richter Hampton
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (6)
Comment Period Closed
Notice
Posted: 04/18/2013
ID: FDA-2010-P-0540-0024
Comment Period Closed
Other
Posted: 04/17/2013
ID: FDA-2010-P-0540-0023
Comment Period Closed
Other
Posted: 05/31/2011
ID: FDA-2010-P-0540-0016
Comment Period Closed
Other
Posted: 03/29/2011
ID: FDA-2010-P-0540-0014
Comment Period Closed
Other
Posted: 11/10/2010
ID: FDA-2010-P-0540-0001

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 02/03/2011
ID: FDA-2010-P-0540-0012
Comments Not Accepted
Supporting & Related Material
Posted: 02/03/2011
ID: FDA-2010-P-0540-0009
Comments Not Accepted
Supporting & Related Material
Posted: 02/03/2011
ID: FDA-2010-P-0540-0010

Comments

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11
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.