NDA 020989

DAIICHI SANKYO INC

FDA Drug Application

Application #020989

Documents

• Letter: 2000-01-11
• Letter: 2005-12-16
• Label: 2005-12-15
• Letter: 2006-12-28
• Label: 2000-01-11
• Label: 2006-12-14
• Review: 2000-01-11

Application Sponsors

NDA 020989

DAIICHI SANKYO INC

Marketing Status

• Prescription: 002

Application Products

002

CAPSULE;ORAL

30MG

1

EVOXAC

CEVIMELINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2000-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-01-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-12-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-11-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	12	Null	0

TE Codes

002

Prescription

AB

CDER Filings

DAIICHI SANKYO INC

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(
    [0] => Array
        (
            [ApplNo] => 20989
            [companyName] => DAIICHI SANKYO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVOXAC","activeIngredients":"CEVIMELINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/08\/2006","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020989s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020989s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20989lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EVOXAC","submission":"CEVIMELINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2006-12-08
        )

)