To Impose A 30-Month Stay of Approval on the Pending ANDA Referencing ORACEA-CLOSED

Docket ID: FDA-2009-P-0225
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Status: CLOSED-Per letter of 11/10/2009
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: To Impose A 30 month Stay of Approval on the Pending ANDA Referencing ORACEA
Keyword(s): CDER-CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P

Primary Documents

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Comment Period Closed
Posted: 11/18/2009
ID: FDA-2009-P-0225-0007
Comment Period Closed
Posted: 06/04/2009
ID: FDA-2009-P-0225-0002
Comment Period Closed
Posted: 06/04/2009
ID: FDA-2009-P-0225-0001

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 07/16/2009
ID: FDA-2009-P-0225-0004


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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.