NDA 019633

B BRAUN

FDA Drug Application

Application #019633

Application Sponsors

NDA 019633

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

LIQUID;N/A

100%

1

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

STERILE WATER FOR INJECTION

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1988-02-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-11-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2014-08-29	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	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	31	Null	0

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19633
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERILE WATER FOR INJECTION IN PLASTIC CONTAINER","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100%","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STERILE WATER FOR INJECTION IN PLASTIC CONTAINER","submission":"STERILE WATER FOR INJECTION","actionType":"100%","submissionClassification":"LIQUID;N\/A","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)