BLA 125553

SANDOZ INC

FDA Drug Application

Application #125553

Documents

• Letter: 2015-03-06
• Letter: 2016-03-04
• Label: 2016-03-04
• Review: 2015-04-20
• Label: 2015-03-06
• Summary Review: 2015-04-20
• Label: 2017-02-21
• Letter: 2017-02-23
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric DD Summary Review: 1900-01-01
• Pediatric Addendum: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Label: 2019-08-02
• Letter: 2019-08-02
• Label: 2021-07-27
• Letter: 2021-07-27

Application Sponsors

BLA 125553

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	300 mcg/0.5 mL	0	ZARXIO	FILGRASTIM-SNDZ
002	INJECTABLE;INJECTION	480 mcg/0.8 mL	0	ZARXIO	FILGRASTIM-SNDZ

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-03-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-02-17	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-08-01	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-07-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	7	Null	7
SUPPL	17	Null	15
SUPPL	23	Null	7

CDER Filings

SANDOZ INC

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(
    [0] => Array
        (
            [ApplNo] => 125553
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZARXIO","activeIngredients":"FILGRASTIM-SNDZ","strength":"300 mcg\/0.5 mL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ZARXIO","activeIngredients":"FILGRASTIM-SNDZ","strength":"480 mcg\/0.8 mL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/01\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125553s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125553s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125553s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125553s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125553s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125553lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/06\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125553lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125553Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125553Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125553Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/01\/2019","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125553s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125553Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"02\/17\/2017","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125553s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125553Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2016","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125553s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125553Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-08-01
        )

)