NDA 208374

BAXTER HLTHCARE CORP

FDA Drug Application

Application #208374

Documents

• Label: 2017-12-26
• Letter: 2017-12-27
• Review: 2018-02-20
• Label: 2021-01-08
• Letter: 2021-01-12

Application Sponsors

NDA 208374

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	250MG/50ML (5MG/ML)	1	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	BIVALIRUDIN
002	SOLUTION;INTRAVENOUS	500MG/100ML (5MG/ML)	1	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	BIVALIRUDIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-12-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-01-08	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208374
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIVALIRUDIN IN 0.9% SODIUM CHLORIDE","activeIngredients":"BIVALIRUDIN","strength":"250MG\/50ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"BIVALIRUDIN IN 0.9% SODIUM CHLORIDE","activeIngredients":"BIVALIRUDIN","strength":"500MG\/100ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208374s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/21\/2017","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\\\/2017\\\/208374s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208374Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208374Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)