ANDA 085870

B BRAUN

FDA Drug Application

Application #085870

Application Sponsors

ANDA 085870

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MEQ/ML

0

POTASSIUM CHLORIDE

POTASSIUM CHLORIDE

FDA Submissions

	ORIG	1	AP	1978-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-07-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-07-22
LABELING; Labeling	SUPPL	14	AP	1990-02-22
LABELING; Labeling	SUPPL	15	AP	1992-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-10-07
LABELING; Labeling	SUPPL	20	AP	2004-03-19
LABELING; Labeling	SUPPL	38	AP	2022-12-06	STANDARD
LABELING; Labeling	SUPPL	39	AP	2022-12-02	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	1
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	38	Null	7
SUPPL	39	Null	7

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85870
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"2MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"2MEQ\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)