NDA 204957

B BRAUN MEDICAL INC

FDA Drug Application

Application #204957

Documents

• Letter: 2021-02-22
• Label: 2021-02-19
• Review: 2021-09-01

Application Sponsors

NDA 204957

B BRAUN MEDICAL INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	1GM/100ML?(10MG/ML)	0	ACETAMINOPHEN	ACETAMINOPHEN
002	SOLUTION;INTRAVENOUS	500MG/50ML?(10MG/ML)	0	ACETAMINOPHEN	ACETAMINOPHEN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-02-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

B BRAUN MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204957
            [companyName] => B BRAUN MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML\u00a0(10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"500MG\/50ML\u00a0(10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/18\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204957s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204957s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/204957Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-18
        )

)