NDA 019018

B BRAUN

FDA Drug Application

Application #019018

Documents

• Label: 2004-04-05
• Letter: 2004-03-28
• Letter: 2020-11-16
• Label: 2020-11-23

Application Sponsors

NDA 019018

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	6% (6GM/100ML)	1	TROPHAMINE	AMINO ACIDS
003	INJECTABLE;INJECTION	10% (10GM/100ML)	1	TROPHAMINE 10%	AMINO ACIDS

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-07-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	1986-10-09
LABELING; Labeling	SUPPL	3	AP	1987-07-09
LABELING; Labeling	SUPPL	4	AP	1988-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-09-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	1988-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2004-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2013-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2014-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2020-10-26	N/A

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	26	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19018
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TROPHAMINE","activeIngredients":"AMINO ACIDS","strength":"6% (6GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TROPHAMINE 10%","activeIngredients":"AMINO ACIDS","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/24\/2004","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19018scs018_trophamine_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"TROPHAMINE","submission":"AMINO ACIDS","actionType":"6% (6GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TROPHAMINE 10%","submission":"AMINO ACIDS","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-03-24
        )

)