NDA 210997

EXELA PHARMA SCS LLC

FDA Drug Application

Application #210997

Documents

• Label: 2018-07-12
• Label: 2018-07-12
• Letter: 2018-07-16
• Letter: 2018-07-16
• Review: 2018-11-13
• Review: 2018-11-13

Application Sponsors

NDA 210997

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	0.2MG/ML (0.2MG/ML)	0	GLYRX-PF	GLYCOPYRROLATE
002	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	0.4MG/2ML (0.2MG/ML)	0	GLYRX-PF	GLYCOPYRROLATE
003	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	1MG/5ML (0.2MG/ML)	0	GLYRX-PF	GLYCOPYRROLATE
004	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	0.6MG/3ML (0.2MG/ML)	0	GLYRX-PF	GLYCOPYRROLATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-07-11	STANDARD
EFFICACY; Efficacy	ORIG	2	AP	2018-07-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	15

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210997
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYRX-PF","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GLYRX-PF","activeIngredients":"GLYCOPYRROLATE","strength":"0.4MG\/2ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GLYRX-PF","activeIngredients":"GLYCOPYRROLATE","strength":"1MG\/5ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GLYRX-PF","activeIngredients":"GLYCOPYRROLATE","strength":"0.6MG\/3ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/11\/2018","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210997s000lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210997s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/11\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210997s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210997Orig1s000,210997Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210997Orig1s000,210997Orig2s000TOC.cfm\"}]","notes":">"},{"actionDate":"07\/11\/2018","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\\\/2018\\\/210997s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210997Orig1s000,210997Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210997Orig1s000,210997Orig2s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-07-11
        )

)