BLA 208157

BAXTER HLTHCARE CORP

FDA Drug Application

Application #208157

Documents

• Label: 2020-03-23
• Letter: 2020-03-23
• Review: 2020-03-23
• Other: 2020-04-07
• Letter: 2020-06-05

Application Sponsors

BLA 208157

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

100 UNITS/100ML (1 UNIT/ML)

0

MYXREDLIN

INSULIN HUMAN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-06-20	STANDARD
LABELING; Labeling	SUPPL	2	TA	2020-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208157
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYXREDLIN","activeIngredients":"INSULIN HUMAN","strength":"100 UNITS\/100ML (1 UNIT\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/20\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208157s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208157s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208157Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/208157Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/04\/2020","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208157Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-04
        )

)