NDA 018681

B BRAUN

FDA Drug Application

Application #018681

Documents

• Label: 2014-09-03

Application Sponsors

NDA 018681

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

1

LACTATED RINGER'S IN PLASTIC CONTAINER

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1982-12-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-03-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	1985-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-03-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	1985-07-16
LABELING; Labeling	SUPPL	8	AP	1985-11-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-08-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	2007-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2014-09-02	N/A

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	27	Null	15

TE Codes

001

Prescription

AT

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18681
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACTATED RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/02\/2014","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018681s027lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LACTATED RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-09-02
        )

)