NDA 020738

ABBVIE

FDA Drug Application

Application #020738

Documents

• Letter: 2003-10-17
• Label: 2004-06-18
• Label: 2011-05-05
• Label: 2012-01-23
• Label: 2012-09-14
• Review: 2011-05-06
• Letter: 2004-06-18
• Letter: 2011-05-06
• Letter: 2012-01-23
• Letter: 2012-09-14
• Letter: 2014-07-24
• Label: 2014-07-24
• Review: 2003-08-07
• Review: 2001-07-05
• Other Important Information from FDA: 2011-12-22

Application Sponsors

NDA 020738

ABBVIE

Marketing Status

• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

004	TABLET;ORAL	EQ 300MG BASE	0	TEVETEN	EPROSARTAN MESYLATE
005	TABLET;ORAL	EQ 400MG BASE	1	TEVETEN	EPROSARTAN MESYLATE
006	TABLET;ORAL	EQ 600MG BASE	1	TEVETEN	EPROSARTAN MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-05-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-10-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-10-16	STANDARD
LABELING; Labeling	SUPPL	26	AP	2011-05-03	UNKNOWN
LABELING; Labeling	SUPPL	27	AP	2012-01-19	UNKNOWN
LABELING; Labeling	SUPPL	28	AP	2012-09-12	UNKNOWN
LABELING; Labeling	SUPPL	29	AP	2014-07-22	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	26	Null	6
SUPPL	27	Null	6
SUPPL	28	Null	7
SUPPL	29	Null	7

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20738
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEVETEN","activeIngredients":"EPROSARTAN MESYLATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEVETEN","activeIngredients":"EPROSARTAN MESYLATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TEVETEN","activeIngredients":"EPROSARTAN MESYLATE","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/22\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020738s029lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020738s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020738s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2011","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020738s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/1998","submission":"SUPPL-1","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/20738S001_TEVETEN_PRNTLBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TEVETEN","submission":"EPROSARTAN MESYLATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TEVETEN","submission":"EPROSARTAN MESYLATE","actionType":"EQ 400MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TEVETEN","submission":"EPROSARTAN MESYLATE","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-07-22
        )

)