NDA 018676

B BRAUN

FDA Drug Application

Application #018676

Documents

• Letter: 2004-05-03
• Label: 2004-05-04

Application Sponsors

NDA 018676

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

8% (8GM/100ML)

0

HEPATAMINE 8%

AMINO ACIDS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1982-08-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	1982-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-03-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	1988-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-04-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	1985-07-16
LABELING; Labeling	SUPPL	8	AP	1986-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-11-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	1987-07-09
LABELING; Labeling	SUPPL	11	AP	1988-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2004-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2013-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2014-11-17	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	27	Null	0
SUPPL	32	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18676
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPATAMINE 8%","activeIngredients":"AMINO ACIDS","strength":"8% (8GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2004","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18676scs022_hepatamine_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"HEPATAMINE 8%","submission":"AMINO ACIDS","actionType":"8% (8GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-04-29
        )

)