BLA 209196

SANOFI-AVENTIS US

FDA Drug Application

Application #209196

Documents

• Label: 2020-03-23
• Letter: 2020-03-23
• Review: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Letter: 2020-03-23
• Other: 2020-03-23
• Label: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23

Application Sponsors

BLA 209196

SANOFI-AVENTIS US

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	0	ADMELOG	INSULIN LISPRO
002	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	0	ADMELOG SOLOSTAR	INSULIN LISPRO
003	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	0	ADMELOG	INSULIN LISPRO

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-12-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-11-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-11-15	901 REQUIRED

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15

CDER Filings

SANOFI-AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209196
            [companyName] => SANOFI-AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADMELOG","activeIngredients":"INSULIN LISPRO","strength":"1000 UNITS\/10ML (100 UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ADMELOG","activeIngredients":"INSULIN LISPRO","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ADMELOG SOLOSTAR","activeIngredients":"INSULIN LISPRO","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209196s004s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209196s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209196s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209196Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209196Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209196s004s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/01\/2018","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2018","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-15
        )

)