NDA 209347

EXELA PHARMA SCS LLC

FDA Drug Application

Application #209347

Documents

• Label: 2017-02-21
• Letter: 2017-02-21
• Letter: 2017-09-22
• Label: 2017-09-27
• Review: 2018-02-20

Application Sponsors

NDA 209347

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

500MG/250ML (2MG/ML)

1

GANZYK-RTU

GANCICLOVIR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2017-12-05	N/A
LABELING; Labeling	SUPPL	3	AP	2017-12-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209347
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANZYK-RTU","activeIngredients":"GANCICLOVIR","strength":"500MG\/250ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/20\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209347s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209347s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209347lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/17\/2017","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\\\/2017\\\/209347lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209347Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209347Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/29\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/05\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209347s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209347Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-12-29
        )

)