Refuse to Approve King's Remoxy NDA Unless the Conditions Specified In the Petition Are Satisfied- CLOSED

 
Docket ID: FDA-2011-P-0045
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: CLOSED-Closed per letter of 7/13/2011
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Refuse to Approve King's Remoxy NDA Unless the Conditions Specified in the Petition are Satisfied
Keyword(s): Remoxy, Extended, Oxycodone, CDER-CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (3)
Comment Period Closed
Other
Posted: 07/21/2011
ID: FDA-2011-P-0045-0006
Other
Posted: 02/08/2011
ID: FDA-2011-P-0045-0001
Comment Period Closed
Other
Posted: 02/08/2011
ID: FDA-2011-P-0045-0005

Supporting Documents

View All  (3)
Comments Not Accepted
Supporting & Related Material
Posted: 02/08/2011
ID: FDA-2011-P-0045-0003
Comments Not Accepted
Supporting & Related Material
Posted: 02/08/2011
ID: FDA-2011-P-0045-0004
Comments Not Accepted
Supporting & Related Material
Posted: 02/08/2011
ID: FDA-2011-P-0045-0002

Comments

 
No comments posted.

0
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.