Refrain from Approving Any Abbreviated New Drug Application for Which Dovonex® Cream (calcipotriene 0.005%) is the Reference Listed Drug Until Certain Conditions Are Satisfied-CLOSED

 
Docket ID: FDA-2011-P-0593
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Refrain from Approving Any Abbreviated New Drug Application for Which Dovonex® Cream (calcipotriene 0.005%) is the Reference Listed Drug Until Certain Conditions Are Satisfied
Keyword(s): LEO, NDA, Dovonex® Cream, Calcipotriene 0.005%, Refrain from Approving, CDER-CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (3)
Comment Period Closed
Other
Posted: 01/18/2012
ID: FDA-2011-P-0593-0003
Other
Posted: 09/01/2011
ID: FDA-2011-P-0593-0001
Comment Period Closed
Other
Posted: 09/01/2011
ID: FDA-2011-P-0593-0002

Supporting Documents

 
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