Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Which Taclonex® Ointment (Calcipotriene 0.005% & Betamethasone Dipropionate 0.064%) & Taclonex Scalp® Topical Suspension (Calcipotriene 0.005% & Betamthasone Dipropionate 0.064%) Is the Reference List Drug (RLD) Until the Following Conditions Are Satisfied-CLOSED

Docket ID: FDA-2011-P-0565
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 Approval of ANDA, Which Taclonex® Ointment and Taclonex Scalp® Topical Suspension is the RLD
Keyword(s): CDER, 22-185, HPA-Axis, NDA's 21-282, Hypercalciuria, Hypercalcemia, Urinary Calcium, Talconex Scalp®, Talconex® Ointment, Calcipotriene 0.005%, CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P

Primary Documents

View All  (3)
Comment Period Closed
Posted: 01/18/2012
ID: FDA-2011-P-0565-0003
Comment Period Closed
Posted: 08/15/2011
ID: FDA-2011-P-0565-0002
Posted: 08/15/2011
ID: FDA-2011-P-0565-0001

Supporting Documents

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Comments Received*
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