NDA 021268

ABBVIE

FDA Drug Application

Application #021268

Documents

• Letter: 2005-07-15
• Letter: 2011-05-25
• Letter: 2011-05-25
• Label: 2011-05-23
• Label: 2011-05-23
• Label: 2014-07-24
• Other Important Information from FDA: 2011-12-22
• Letter: 2001-11-01
• Letter: 2003-10-17
• Letter: 2003-07-10
• Letter: 2012-01-23
• Letter: 2012-09-14
• Letter: 2014-07-24
• Label: 2001-11-01
• Label: 2012-01-23
• Label: 2012-09-14
• Review: 2002-03-05

Application Sponsors

NDA 021268

ABBVIE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	600MG;12.5MG	0	TEVETEN HCT	EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	600MG;25MG	0	TEVETEN HCT	EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2001-11-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	2003-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2003-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2005-07-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2011-05-19	UNKNOWN
LABELING; Labeling	SUPPL	16	AP	2011-05-19	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2012-01-19	UNKNOWN
LABELING; Labeling	SUPPL	18	AP	2012-09-12	UNKNOWN
LABELING; Labeling	SUPPL	19	AP	2014-07-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	6
SUPPL	19	Null	6

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21268
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEVETEN HCT","activeIngredients":"EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE","strength":"600MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEVETEN HCT","activeIngredients":"EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE","strength":"600MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/22\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021268s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021268s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2012","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021268s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021268s015s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021268s015s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-268_TEVETEN_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TEVETEN HCT","submission":"EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE","actionType":"600MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TEVETEN HCT","submission":"EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE","actionType":"600MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-07-22
        )

)