ALVOGEN FDA Approval NDA 019777

Application #019777

Documents

Letter	2000-02-07
Letter	2005-05-25
Letter	2007-07-24
Letter	2007-10-10
Letter	2009-05-26
Letter	2014-06-27
Letter	2011-08-09
Letter	2012-05-04
Letter	2012-08-16
Letter	2016-04-22
Label	2009-05-25
Label	2009-11-19
Label	2012-05-07
Label	2012-03-29
Label	2012-11-02
Label	2013-11-21
Label	2015-01-09
Label	2015-08-26
Letter	2003-07-06
Letter	2004-04-07
Letter	2003-07-06
Letter	2006-06-20
Letter	2010-01-07
Letter	2012-04-02
Letter	2012-11-05
Letter	2013-11-07
Letter	2014-12-30
Letter	2015-08-27
Review	2003-08-05
Review	2001-09-18
Review	2003-08-05
Review	2003-08-05
Review	2003-08-05
Review	2001-09-18
Review	2003-08-05
Review	2003-08-08
Review	1997-01-08
Review	1998-11-06
Review	2005-12-16
Review	2004-09-08
Review	2004-09-08
Other Important Information from FDA	2006-06-09
Label	2003-07-08
Label	2004-01-02
Label	2014-06-30
Label	2011-08-12
Label	2012-08-15
Label	2016-04-29
Review	2001-09-18
Review	2001-09-18
Review	2001-09-18
Review	2003-08-05
Review	2003-08-05
Review	2003-08-05
Review	2003-08-05
Review	2003-08-05
Review	2003-08-08
Review	2003-08-08
Review	1998-05-01
Review	1999-01-20
Label	2017-07-25
Letter	2017-07-25

Application Sponsors

NDA 019777

ALVOGEN

Marketing Status

Prescription	001
Prescription	002
Prescription	003
Prescription	004
Prescription	005
Prescription	006

Application Products

001	TABLET;ORAL	5MG	1	ZESTRIL	LISINOPRIL
002	TABLET;ORAL	10MG	1	ZESTRIL	LISINOPRIL
003	TABLET;ORAL	20MG	1	ZESTRIL	LISINOPRIL
004	TABLET;ORAL	40MG	1	ZESTRIL	LISINOPRIL
005	TABLET;ORAL	2.5MG	1	ZESTRIL	LISINOPRIL
006	TABLET;ORAL	30MG	1	ZESTRIL	LISINOPRIL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1988-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-01-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	1989-04-11
LABELING; Labeling	SUPPL	5	AP	1989-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-09-05	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1993-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-11-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	1990-10-17
LABELING; Labeling	SUPPL	10	AP	1991-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1991-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-02-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	1992-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-05-26	STANDARD
LABELING; Labeling	SUPPL	18	AP	1993-03-31	STANDARD
LABELING; Labeling	SUPPL	19	AP	1993-09-23	STANDARD
LABELING; Labeling	SUPPL	20	AP	1995-06-13	STANDARD
LABELING; Labeling	SUPPL	21	AP	1994-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-05-17	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	1995-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1995-06-05	STANDARD
LABELING; Labeling	SUPPL	25	AP	1995-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1995-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1995-10-26	STANDARD
LABELING; Labeling	SUPPL	30	AP	1995-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-10-11	STANDARD
LABELING; Labeling	SUPPL	32	AP	1997-01-08	STANDARD
LABELING; Labeling	SUPPL	33	AP	1998-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1998-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1999-01-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1999-02-24	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2000-02-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1999-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2000-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2000-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2000-12-15	STANDARD
LABELING; Labeling	SUPPL	42	AP	2003-07-01	STANDARD
LABELING; Labeling	SUPPL	43	AP	2004-03-30	STANDARD
EFFICACY; Efficacy	SUPPL	44	AP	2003-07-01	STANDARD
LABELING; Labeling	SUPPL	45	AP	2002-10-17	STANDARD
LABELING; Labeling	SUPPL	49	AP	2005-05-24	STANDARD
LABELING; Labeling	SUPPL	50	AP	2006-06-16	STANDARD
LABELING; Labeling	SUPPL	52	AP	2007-07-16	STANDARD
LABELING; Labeling	SUPPL	53	AP	2007-10-04	STANDARD
LABELING; Labeling	SUPPL	54	AP	2009-05-20	STANDARD
LABELING; Labeling	SUPPL	56	AP	2009-11-06	STANDARD
LABELING; Labeling	SUPPL	57	AP	2014-06-26	STANDARD
LABELING; Labeling	SUPPL	58	AP	2011-08-04	UNKNOWN
LABELING; Labeling	SUPPL	59	AP	2012-05-02	UNKNOWN
LABELING; Labeling	SUPPL	60	AP	2012-03-29	UNKNOWN
LABELING; Labeling	SUPPL	61	AP	2012-10-31	UNKNOWN
LABELING; Labeling	SUPPL	62	AP	2012-08-13	STANDARD
LABELING; Labeling	SUPPL	63	AP	2013-11-05	STANDARD
LABELING; Labeling	SUPPL	64	AP	2014-12-24	STANDARD
LABELING; Labeling	SUPPL	73	AP	2015-08-25	STANDARD
LABELING; Labeling	SUPPL	74	AP	2016-04-21	STANDARD
LABELING; Labeling	SUPPL	76	AP	2017-07-21	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	31	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	26
SUPPL	56	Null	6
SUPPL	57	Null	6
SUPPL	58	Null	6
SUPPL	59	Null	6
SUPPL	60	Null	6
SUPPL	61	Null	7
SUPPL	62	Null	7
SUPPL	63	Null	15
SUPPL	64	Null	6
SUPPL	73	Null	7
SUPPL	74	Null	15
SUPPL	76	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19777
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZESTRIL","activeIngredients":"LISINOPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZESTRIL","activeIngredients":"LISINOPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZESTRIL","activeIngredients":"LISINOPRIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZESTRIL","activeIngredients":"LISINOPRIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZESTRIL","activeIngredients":"LISINOPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZESTRIL","activeIngredients":"LISINOPRIL","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/21\/2017","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019777s076lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2016","submission":"SUPPL-74","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019777s074lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2015","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019777s073lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2014","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019777s064lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2014","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019777s057lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2013","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019777s063lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019777s061lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2012","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019777s062lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2012","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019777s059lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2012","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019777s060lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019777s058lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019777s056lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2009","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019777s054lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2003","submission":"SUPPL-44","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/01\/2003","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19777se5-044,slr042_zestril_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZESTRIL","submission":"LISINOPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTRIL","submission":"LISINOPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTRIL","submission":"LISINOPRIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTRIL","submission":"LISINOPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTRIL","submission":"LISINOPRIL","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-21
        )

)

NDA 019777

ALVOGEN

FDA Drug Application

Application #019777

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

ALVOGEN