NDA 208216

ACTAVIS LLC

FDA Drug Application

Application #208216

Documents

• Letter: 2016-05-04
• Label: 2016-05-03
• Review: 2017-07-20
• Label: 2018-01-11
• Letter: 2018-01-11
• Letter: 2018-10-23
• Label: 2018-10-24
• Label: 2020-07-14
• Letter: 2020-07-17

Application Sponsors

NDA 208216

ACTAVIS LLC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS, SUBCUTANEOUS

100MG/VIAL

0

AZACITIDINE

AZACITIDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2016-04-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-10-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-07-13	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACTAVIS LLC

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(
    [0] => Array
        (
            [ApplNo] => 208216
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/13\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208216s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208216s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208216s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208216s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/2016","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\\\/2016\\\/208216s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208216Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208216Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/13\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208216s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208216Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"10\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208216s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208216Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"01\/10\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208216s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208216Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-07-13
        )

)