Request That the Food and Drug Adminstration Make a Determination That OxyContin (Oxycodone Hydrochloride Extended-Releases) Tablets, 10 mg, 15 mg, 20 mg, 40 mg, 60 mg, 80 mg and 160 mg Withdrawn From Sale for Reasons Other Than Safety or Effectiveness - CLOSED

 
Docket ID: FDA-2011-P-0473
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: FDA Make a Determination That OxyContin (Oxycodone Hydrochloride ER) Tablets, 10 mg, 15 mg, 20 mg, 40 mg, 60 mg, 80 mg and 160 mg Withdrawn From Sale for Reasons Other Than Safety or Effectiveness
Keyword(s): cder, orange book, oxycontin, 10 mg, 15 mg, 20 mg, 40 mg 60 mg 160 mg, NDA 20-553, hydrochloride extended-release
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

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Comment Period Closed
Notice
Posted: 04/18/2013
ID: FDA-2011-P-0473-0011
Comment Period Closed
Other
Posted: 04/17/2013
ID: FDA-2011-P-0473-0010
Comment Period Closed
Other
Posted: 12/13/2011
ID: FDA-2011-P-0473-0004
Comment Period Closed
Other
Posted: 06/26/2011
ID: FDA-2011-P-0473-0001
Comment Period Closed
Other
Posted: 06/26/2011
ID: FDA-2011-P-0473-0002

Supporting Documents

 
No documents available.

Comments

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6
Comments Received*
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