ANDA 091387

B BRAUN

FDA Drug Application

Application #091387

Documents

• Letter: 2010-02-17

Application Sponsors

ANDA 091387

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

0

BALANCED SALT

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE

FDA Submissions

	ORIG	1	AP	2010-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2022-01-28	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AT

CDER Filings

B BRAUN

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(
    [0] => Array
        (
            [ApplNo] => 91387
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BALANCED SALT","activeIngredients":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","strength":"0.48MG\/ML;0.3MG\/ML;0.75MG\/ML;3.9MG\/ML;6.4MG\/ML;1.7MG\/ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BALANCED SALT","submission":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE","actionType":"0.48MG\/ML;0.3MG\/ML;0.75MG\/ML;3.9MG\/ML;6.4MG\/ML;1.7MG\/ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)