NDA 209570

CHEMO RESEARCH SL

FDA Drug Application

Application #209570

Documents

• Letter: 2017-08-30
• Label: 2017-08-30
• Review: 2017-10-10
• Letter: 2019-11-12
• Label: 2021-12-17
• Letter: 2021-12-21

Application Sponsors

NDA 209570

CHEMO RESEARCH SL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	12.5MG	1	BENZNIDAZOLE	BENZNIDAZOLE
002	TABLET;ORAL	100MG	1	BENZNIDAZOLE	BENZNIDAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-08-29	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2021-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7

CDER Filings

CHEMO RESEARCH SL

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(
    [0] => Array
        (
            [ApplNo] => 209570
            [companyName] => CHEMO RESEARCH SL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZNIDAZOLE","activeIngredients":"BENZNIDAZOLE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BENZNIDAZOLE","activeIngredients":"BENZNIDAZOLE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/29\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209570lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209570lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209570Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209570Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209570Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-07
        )

)