ACTAVIS LLC FDA Approval NDA 203551

NDA 203551

ACTAVIS LLC

FDA Drug Application

Application #203551

Documents

Letter2013-04-16
Label2013-11-04
Label2014-09-19
Review2013-10-21
Summary Review2013-10-21
Letter2013-11-07
Letter2014-09-23
Label2013-05-07
Label2018-04-12
Letter2018-04-16
Letter2019-07-10
Label2019-07-10
Letter2020-07-28
Label2020-07-28

Application Sponsors

NDA 203551ACTAVIS LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION20MG/ML (20MG/ML)0DOCETAXELDOCETAXEL
002INJECTABLE;INJECTION80MG/4ML (20MG/ML)0DOCETAXELDOCETAXEL
003INJECTABLE;INJECTION140MG/7ML (20MG/ML)0DOCETAXELDOCETAXEL
004INJECTABLE;INJECTION160MG/8ML (20MG/ML)0DOCETAXELDOCETAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2013-04-12STANDARD
LABELING; LabelingSUPPL2AP2014-09-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2015-04-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2015-09-21STANDARD
LABELING; LabelingSUPPL5AP2018-04-11STANDARD
LABELING; LabelingSUPPL7AP2019-07-09STANDARD
LABELING; LabelingSUPPL9AP2020-07-27STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null6
SUPPL3Null0
SUPPL4Null0
SUPPL5Null15
SUPPL7Null7
SUPPL9Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
004PrescriptionAP

CDER Filings

ACTAVIS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203551
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"140MG\/7ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203551s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203551s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203551Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203551Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203551s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203551s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203551Orig1s000lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/12\/2013","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\\\/2013\\\/203551Orig1s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203551Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203551_docetaxel_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203551Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203551s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203551Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"04\/11\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203551Orig1s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203551Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/21\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/17\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203551s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203551Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"11\/04\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203551s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203551Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-07-09
        )

)
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