BLA 020032

ABBVIE

FDA Drug Application

Application #020032

Documents

• Letter: 2020-03-23
• Letter: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-03-23
• Letter: 2020-03-23
• Other: 2020-03-23
• Label: 2020-10-27
• Letter: 2020-10-30
• Letter: 2022-08-03
• Label: 2022-08-05

Application Sponsors

BLA 020032

ABBVIE

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;INTRATRACHEAL

25MG/ML

0

SURVANTA

BERACTANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-09-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	1995-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-12-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-10-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-12-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2005-04-28	STANDARD
LABELING; Labeling	SUPPL	35	AP	2009-02-10	STANDARD
LABELING; Labeling	SUPPL	36	AP	2009-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2013-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2013-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2016-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2014-12-03	STANDARD
LABELING; Labeling	SUPPL	45	AP	2019-12-16	STANDARD
LABELING; Labeling	SUPPL	46	AP	2020-10-26	STANDARD
LABELING; Labeling	SUPPL	47	AP	2022-07-15	STANDARD

Submissions Property Types

ORIG	1	Null	11
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	13	Null	14
SUPPL	14	Null	14
SUPPL	15	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	20	Null	14
SUPPL	23	Null	14
SUPPL	26	Null	14
SUPPL	41	Null	14
SUPPL	42	Null	14
SUPPL	43	Null	14
SUPPL	44	Null	14
SUPPL	45	Null	6
SUPPL	46	Null	7
SUPPL	47	Null	46

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20032
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SURVANTA","activeIngredients":"BERACTANT","strength":"25MG\/ML","dosageForm":"SUSPENSION;INTRATRACHEAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/26\/2020","submission":"SUPPL-46","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020032s046lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2020","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020032s046lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020032s045lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SURVANTA","submission":"BERACTANT","actionType":"25MG\/ML","submissionClassification":"SUSPENSION;INTRATRACHEAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-10-26
        )

)