BLA 020744

CHIESI USA INC

FDA Drug Application

Application #020744

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Label: 2021-05-18
• Letter: 2021-05-19

Application Sponsors

BLA 020744

CHIESI USA INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;INTRATRACHEAL

80MG/ML

0

CUROSURF

PORACTANT ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2004-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-21	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2002-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-12-13	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2014-02-12	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2014-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2015-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2016-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2016-11-01	STANDARD
LABELING; Labeling	SUPPL	40	AP	2019-12-16	STANDARD
LABELING; Labeling	SUPPL	43	AP	2021-05-17	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	25	Null	14
SUPPL	26	Null	14
SUPPL	27	Null	14
SUPPL	28	Null	7
SUPPL	29	Null	14
SUPPL	30	Null	14
SUPPL	40	Orphan	5
SUPPL	43	Null	7

CDER Filings

CHIESI USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20744
            [companyName] => CHIESI USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CUROSURF","activeIngredients":"PORACTANT ALFA","strength":"80MG\/ML","dosageForm":"SUSPENSION;INTRATRACHEAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CUROSURF","submission":"PORACTANT ALFA","actionType":"80MG\/ML","submissionClassification":"SUSPENSION;INTRATRACHEAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)