Refrain from or Approving Any Application for A 0.6 mg Oral Colchicine Tablet with A Proposed Indication Already Approve for Colcrys® That Is Not Submitted As An Appreviated New Drug Application-CLOSED

 
Docket ID: FDA-2010-P-0614
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Closed per letter of 5/25/2011
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Refrain From or Approving any Application for a 0.6 mg Oral Colchicine Tablet with a Proposed Indication Already Approve for Colcrys® That is not Submitted as an Appreviated New Drug Application
Keyword(s): Criterion, Generic, Androderm, Bioequivalence, CDER-CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (9)
Comment Period Closed
May 25, 2011 11:59 PM ET
Other
ID: FDA-2010-P-0614-0002
Comment Period Closed
Other
Posted: 05/25/2011
ID: FDA-2010-P-0614-0072
Comment Period Closed
Other
Posted: 05/17/2011
ID: FDA-2010-P-0614-0069
Comments Not Accepted
Other
Posted: 05/10/2011
ID: FDA-2010-P-0614-0061
Comment Period Closed
Other
Posted: 04/22/2011
ID: FDA-2010-P-0614-0028

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 06/21/2011
ID: FDA-2010-P-0614-0079
Comments Not Accepted
Supporting & Related Material
Posted: 06/21/2011
ID: FDA-2010-P-0614-0081
Comments Not Accepted
Supporting & Related Material
Posted: 06/21/2011
ID: FDA-2010-P-0614-0080

Comments

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18
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.