NDA 021434

PHARMACIA AND UPJOHN

FDA Drug Application

Application #021434

Documents

• Letter: 2011-06-03
• Letter: 2011-08-26
• Label: 2011-06-07
• Label: 2011-08-24
• Letter: 2004-06-30
• Letter: 2004-04-07
• Label: 2003-03-06
• Review: 2004-12-07
• Review: 2006-10-25
• Label: 2016-12-20
• Letter: 2016-12-22
• Medication Guide: 2016-12-30
• Letter: 2021-02-09
• Label: 2021-02-11
• Medication Guide: 2021-02-11
• Letter: 2021-03-02
• Label: 2021-03-02
• Label: 2023-01-17

Application Sponsors

NDA 021434

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	0.5MG	1	XANAX XR	ALPRAZOLAM
002	TABLET, EXTENDED RELEASE;ORAL	1MG	1	XANAX XR	ALPRAZOLAM
003	TABLET, EXTENDED RELEASE;ORAL	2MG	1	XANAX XR	ALPRAZOLAM
004	TABLET, EXTENDED RELEASE;ORAL	3MG	1	XANAX XR	ALPRAZOLAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-01-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2011-06-01	UNKNOWN
LABELING; Labeling	SUPPL	7	AP	2011-08-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-04-07	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-12-16	901 REQUIRED
LABELING; Labeling	SUPPL	18	AP	2021-03-01	STANDARD
LABELING; Labeling	SUPPL	21	AP	2021-02-05	901 REQUIRED
LABELING; Labeling	SUPPL	22	AP	2023-01-13	STANDARD

Submissions Property Types

SUPPL	6	Null	6
SUPPL	7	Null	6
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	21	Null	31
SUPPL	22	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21434
            [companyName] => UPJOHN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021434s021lbl.pdf#page=26"]
            [products] => [{"drugName":"XANAX XR","activeIngredients":"ALPRAZOLAM","strength":"0.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"XANAX XR","activeIngredients":"ALPRAZOLAM","strength":"1MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"XANAX XR","activeIngredients":"ALPRAZOLAM","strength":"2MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"XANAX XR","activeIngredients":"ALPRAZOLAM","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/01\/2021","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021434s018lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2021","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021434s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021434s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021434s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021434s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2011","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018276s044,021434s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021434lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"XANAX XR","submission":"ALPRAZOLAM","actionType":"0.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XANAX XR","submission":"ALPRAZOLAM","actionType":"1MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XANAX XR","submission":"ALPRAZOLAM","actionType":"2MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"XANAX XR","submission":"ALPRAZOLAM","actionType":"3MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-03-01
        )

)