NDA 022328

PURDUE PHARMA

FDA Drug Application

Application #022328

Documents

• Letter: 2011-11-28
• Label: 2015-09-14
• Review: 2012-09-05
• Other Important Information from FDA: 2013-04-29
• Summary Review: 2012-09-05
• Letter: 2015-09-15
• Label: 2011-11-28
• Label: 2013-02-08
• Label: 2019-02-07
• Letter: 2019-02-14
• Letter: 2019-08-20
• Label: 2019-08-20
• Medication Guide: 2019-08-20

Application Sponsors

NDA 022328

PURDUE PHARMA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;SUBLINGUAL	1.75MG	1	INTERMEZZO	ZOLPIDEM TARTRATE
002	TABLET;SUBLINGUAL	3.5MG	1	INTERMEZZO	ZOLPIDEM TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-11-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-11-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-09-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-02-06	901 REQUIRED
LABELING; Labeling	SUPPL	8	AP	2019-08-18	901 REQUIRED

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	6
SUPPL	7	Null	15
SUPPL	8	Null	6

CDER Filings

PURDUE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22328
            [companyName] => PURDUE PHARMA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022328s008lbl.pdf#page=20"]
            [products] => [{"drugName":"INTERMEZZO","activeIngredients":"ZOLPIDEM TARTRATE","strength":"1.75MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"INTERMEZZO","activeIngredients":"ZOLPIDEM TARTRATE","strength":"3.5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/18\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022328s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022328s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022328s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022328s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/23\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022328lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INTERMEZZO","submission":"ZOLPIDEM TARTRATE","actionType":"1.75MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"INTERMEZZO","submission":"ZOLPIDEM TARTRATE","actionType":"3.5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-18
        )

)