NDA 020002

B BRAUN

FDA Drug Application

Application #020002

Documents

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

Application Sponsors

NDA 020002

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

33MG/100ML;30MG/100ML;860MG/100ML

0

RINGER'S IN PLASTIC CONTAINER

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-06-16
LABELING; Labeling	SUPPL	32	AP	2021-11-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	32	Null	6

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20002
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"33MG\/100ML;30MG\/100ML;860MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"33MG\/100ML;30MG\/100ML;860MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)