Determine Whether Opana® ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 7.5 mg and 15 mg Have Been Voluntarily Withdrawn, Discontinued or Withheld From Sale for Safety or Efficacy Reasons - CLOSED

 
Docket ID: FDA-2011-P-0182
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: CLOSE Closed per letter of 8/30/2011
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Determine Whether Opana® ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 7.5 mg and 15 mg Have Been Voluntarily Withdrawn, Discontinued or Withheld From Sale for Safety or Efficacy Reasons
Keyword(s): Opana, Oxymorphobe, Hydrochloride, Tablets, CDER
Type: Nonrulemaking
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (4)
Comment Period Closed
Other
Posted: 09/20/2011
ID: FDA-2011-P-0182-0004
Comment Period Closed
Notice
Posted: 08/30/2011
ID: FDA-2011-P-0182-0003
Other
Posted: 03/25/2011
ID: FDA-2011-P-0182-0001
Comment Period Closed
Other
Posted: 03/25/2011
ID: FDA-2011-P-0182-0002

Supporting Documents

 
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