NDA 020577

LUKARE MEDICAL LLC

FDA Drug Application

Application #020577

Application Sponsors

NDA 020577

LUKARE MEDICAL LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRATHECAL

0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML

1

ELLIOTTS B SOLUTION

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-05-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-11-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2015-06-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2012-12-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-07-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-12-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-11-29	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14

CDER Filings

LUKARE MEDICAL LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20577
            [companyName] => LUKARE MEDICAL LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELLIOTTS B SOLUTION","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","strength":"0.2MG\/ML;0.8MG\/ML;0.3MG\/ML;0.3MG\/ML;1.9MG\/ML;7.3MG\/ML;0.2MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ELLIOTTS B SOLUTION","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","actionType":"0.2MG\/ML;0.8MG\/ML;0.3MG\/ML;0.3MG\/ML;1.9MG\/ML;7.3MG\/ML;0.2MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)