NDA 018582

B BRAUN

FDA Drug Application

Application #018582

Documents

• Letter: 2004-01-09
• Label: 2004-01-15

Application Sponsors

NDA 018582

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML

0

PROCALAMINE

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1982-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-09-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	1988-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-06-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	1986-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-11-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	1987-07-09
LABELING; Labeling	SUPPL	17	AP	1987-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1990-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1991-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1994-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1999-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2000-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2003-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2013-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2013-08-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	42	Null	0
SUPPL	47	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18582
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCALAMINE","activeIngredients":"AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"3%;26MG\/100ML;3GM\/100ML;54MG\/100ML;41MG\/100ML;150MG\/100ML;200MG\/100ML;120MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/24\/2003","submission":"SUPPL-31","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/18582scs031_procalAmine_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"PROCALAMINE","submission":"AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"3%;26MG\/100ML;3GM\/100ML;54MG\/100ML;41MG\/100ML;150MG\/100ML;200MG\/100ML;120MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-12-24
        )

)