NDA 020006

B BRAUN

FDA Drug Application

Application #020006

Documents

• Label: 2019-01-10
• Letter: 2019-01-23
• Label: 2019-09-25
• Letter: 2019-09-25

Application Sponsors

NDA 020006

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	5GM/100ML	0	MANNITOL 5% IN PLASTIC CONTAINER	MANNITOL
002	INJECTABLE;INJECTION	10GM/100ML	0	MANNITOL 10% IN PLASTIC CONTAINER	MANNITOL
003	INJECTABLE;INJECTION	15GM/100ML	0	MANNITOL 15% IN PLASTIC CONTAINER	MANNITOL
004	INJECTABLE;INJECTION	20GM/100ML	0	MANNITOL 20% IN PLASTIC CONTAINER	MANNITOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1993-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-07-01	STANDARD
LABELING; Labeling	SUPPL	9	AP	2005-04-20
LABELING; Labeling	SUPPL	25	AP	2019-01-09	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2019-09-24	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	25	Null	6
SUPPL	28	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20006
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MANNITOL 10% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"10GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MANNITOL 15% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"15GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MANNITOL 20% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"20GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MANNITOL 5% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"5GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/24\/2019","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020006s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020006s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MANNITOL 10% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"10GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MANNITOL 15% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"15GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MANNITOL 20% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"20GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MANNITOL 5% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"5GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-09-24
        )

)