NDA 201525

SANDOZ

FDA Drug Application

Application #201525

Documents

• Letter: 2011-07-06
• Letter: 2012-03-19
• Letter: 2014-04-24
• Letter: 2014-11-05
• Label: 2011-06-30
• Label: 2012-03-16
• Label: 2014-04-25
• Label: 2014-11-07
• Label: 2014-11-07
• Summary Review: 2012-01-12
• Letter: 2014-11-05
• Review: 2012-01-12
• Letter: 2016-10-25
• Label: 2019-03-28
• Label: 2019-03-28
• Letter: 2019-03-29
• Letter: 2019-03-29
• Review: 2019-08-07
• Label: 2020-01-06
• Letter: 2020-01-07
• Letter: 2020-08-12
• Label: 2020-08-12
• Label: 2021-01-14
• Letter: 2021-01-14

Application Sponsors

NDA 201525

SANDOZ

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	20MG/2ML (10MG/ML)	0	DOCETAXEL	DOCETAXEL
002	INJECTABLE;INJECTION	80MG/8ML (10MG/ML)	0	DOCETAXEL	DOCETAXEL
003	INJECTABLE;INJECTION	160MG/16ML (10MG/ML)	0	DOCETAXEL	DOCETAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2011-06-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-03-15	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2014-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-08-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-11-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2016-07-25	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-10-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-03-27	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-03-27	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-01-06	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-08-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	11	Null	0
SUPPL	12	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	6
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	22	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

SANDOZ

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201525
            [companyName] => SANDOZ
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/8ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/16ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/11\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201525s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201525s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/06\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201525s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201525s016s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201525s016s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201525s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201525s008s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201525s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201525s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201525s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/29\/2011","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\\\/2011\\\/201525s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201525s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201525_docetaxel_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201525Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/11\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201525s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/201525Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"01\/06\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201525s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/201525Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201525s016s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/27\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201525s016s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"10\/21\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201525Orig1s012ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/201525Orig1s012.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/25\/2016","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201525s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201525Orig1s008,s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/04\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201525s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201525Orig1s008,s009ltr.pdf\"}]","notes":">"},{"actionDate":"08\/18\/2014","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201525s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201525Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"03\/15\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201525s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201525s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-08-11
        )

)