Make a determination that Opana® ER Tablets, 7.5 mg and 15 mg were not discontinued from sale for safety or effectiveness reasons - CLOSED

Docket ID: FDA-2011-P-0209
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Status: CLOSE Closed per letter of 8/30/2011
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): safety/effectiveness , discontinued, 7.5 mg and 15 mg , ER Tablets, Opana® , Determination, cder
Type: Nonrulemaking
Center: CDER
Docket Item Code: P

Primary Documents

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Comment Period Closed
Posted: 09/20/2011
ID: FDA-2011-P-0209-0005
Comment Period Closed
Posted: 08/30/2011
ID: FDA-2011-P-0209-0004
Comment Period Closed
Posted: 04/12/2011
ID: FDA-2011-P-0209-0003
Posted: 04/12/2011
ID: FDA-2011-P-0209-0001

Supporting Documents

View All  (1)
Comments Not Accepted
Supporting & Related Material
Posted: 04/12/2011
ID: FDA-2011-P-0209-0002


No comments posted.

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.