NDA 019632

B BRAUN

FDA Drug Application

Application #019632

Documents

• Letter: 2021-11-04
• Label: 2021-11-05

Application Sponsors

NDA 019632

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

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

0

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	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	1989-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	22	AP	2004-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2016-06-17	STANDARD
LABELING; Labeling	SUPPL	50	AP	2021-11-03	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	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	36	Null	0
SUPPL	50	Null	15

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19632
            [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":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [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":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)