Abbott requests that FDA Refrain from listing a TE rating for any drug approved under § 505 (b) (2) that references AndroGel unless and until it has conducted a notice-and-comment rulemaking

 
Docket ID: FDA-2011-P-0610
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Closed Partial Approval/Denial 7/23/2014
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Abbott requests that FDA Refrain from listing a TE rating for any drug approved under § 505 (b) (2) that references AndroGel unless and until it has conducted a notice-and-comment rulemaking
Keyword(s): cder, Abbott, 505(b)(2), testosterone gel, TE rating, AndroGel
Type: Nonrulemaking
Docket Status: Closed
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (6)
Comment Period Closed
Other
Posted: 07/23/2014
ID: FDA-2011-P-0610-0010
Comment Period Closed
Other
Posted: 06/12/2014
ID: FDA-2011-P-0610-0008
Comment Period Closed
Other
Posted: 12/23/2013
ID: FDA-2011-P-0610-0005
Other
Posted: 04/05/2012
ID: FDA-2011-P-0610-0003
Comment Period Closed
Other
Posted: 09/01/2011
ID: FDA-2011-P-0610-0002

Supporting Documents

View All  (2)
Comments Not Accepted
Supporting & Related Material
Posted: 06/12/2014
ID: FDA-2011-P-0610-0009
Comments Not Accepted
Supporting & Related Material
Posted: 01/07/2013
ID: FDA-2011-P-0610-0004

Comments

View All  (2)

2
Comments Received*
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