BLA 761033

TEVA RESPIRATORY LLC

FDA Drug Application

Application #761033

Documents

• Letter: 2016-03-29
• Label: 2016-03-29
• Review: 2016-05-05
• Summary Review: 2016-05-05
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-01-10
• Letter: 2019-01-18

Application Sponsors

BLA 761033

TEVA RESPIRATORY LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/10ML

0

CINQAIR

RESLIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-03-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-01-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	10	Null	6

CDER Filings

TEVA RESPIRATORY LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761033
            [companyName] => TEVA RESPIRATORY LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CINQAIR","activeIngredients":"RESLIZUMAB","strength":"100MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/09\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/0761033s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761033lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761033Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761033Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761033Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/09\/2019","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/0761033s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761033Orig1s010ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-01-09
        )

)