NDA 210660

EXELA PHARMA SCS LLC

FDA Drug Application

Application #210660

Documents

• Label: 2019-04-22
• Letter: 2019-04-16
• Review: 2019-12-04

Application Sponsors

NDA 210660

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

500MG/10ML (50MG/ML)

1

ELCYS

CYSTEINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-04-16

PRIORITY

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210660
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELCYS","activeIngredients":"CYSTEINE HYDROCHLORIDE","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/16\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210660lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210660lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210660Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210660Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-04-16
        )

)