NDA 021693

SHIONOGI INC

FDA Drug Application

Application #021693

Documents

• Letter: 2006-07-21
• Letter: 2010-09-07
• Letter: 2010-06-29
• Label: 2005-05-17
• Label: 2010-08-28
• Label: 2010-07-01
• Review: 2007-08-22
• Letter: 2005-05-17

Application Sponsors

NDA 021693

SHIONOGI INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

50MG

0

RYBIX ODT

TRAMADOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-05-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-08-13	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2010-06-25	UNKNOWN

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	31
SUPPL	4	Null	7

CDER Filings

SHIONOGI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21693
            [companyName] => SHIONOGI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYBIX ODT","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/13\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021693s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021693s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021693lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RYBIX ODT","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-08-13
        )

)