NDA 204767

FRESENIUS KABI USA

FDA Drug Application

Application #204767

Documents

• Letter: 2015-10-30
• Label: 2015-10-29
• Review: 2016-07-19
• Letter: 2020-11-16
• Label: 2020-11-16
• Letter: 2021-06-25
• Label: 2021-06-28
• Letter: 2021-07-29

Application Sponsors

NDA 204767

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1GM/100ML (10MG/ML)

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2015-10-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-06-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-07-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	6
SUPPL	7	Null	15
SUPPL	8	Null	15

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204767
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/28\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204767s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/28\/2015","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\\\/2015\\\/204767s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204767Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204767Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-10-28
        )

)