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Refuse to Approve Any Abbreviated New Drug Application for a Generic Version of Noven's Daytrana® (Methylphenidate), 10mg,/9hr, 15mg/9hr, 20mg/9hr, 30mg/9hr, Transdermal System, Unless The Conditions Specified In this Petition are Satisfied -CLOSED

Type: Non-Rule Making
KeyWord(s) cder, daytrana, methylphenidate, transdermal systems, NDA No. 021514, 2012-7328, noven, closed
Short title Refuse to Approve Any ANDA for a Generic Version of Noven's Daytran (Methylphenidate), Transdermal System, Unless The Conditions Specified In this Petition are Satisfied
Docket Item Code P
Center CDER

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