NDA 214313

BAXTER HLTHCARE CORP

FDA Drug Application

Application #214313

Documents

• Label: 2021-01-15
• Letter: 2021-01-19
• Review: 2021-07-15
• Letter: 2022-08-18
• Label: 2022-08-19

Application Sponsors

NDA 214313

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	16 MCG/ML	0	NOREPINEPHRINE BITARTRATE;DEXTROSE	NOREPINEPHRINE BITARTRATE;DEXTROSE
002	INJECTABLE;INJECTION	32 MCG/ML	2	NOREPINEPHRINE BITARTRATE;DEXTROSE	NOREPINEPHRINE BITARTRATE;DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2021-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-06-02	STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214313
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOREPINEPHRINE BITARTRATE;DEXTROSE","activeIngredients":"NOREPINEPHRINE BITARTRATE;DEXTROSE","strength":"16 MCG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOREPINEPHRINE BITARTRATE;DEXTROSE","activeIngredients":"NOREPINEPHRINE BITARTRATE;DEXTROSE","strength":"32 MCG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214313s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/15\/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\\\/214313s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214313Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-01-15
        )

)