NDA 207987

BELCHER

FDA Drug Application

Application #207987

Documents

• Letter: 2018-06-27
• Label: 2018-07-04
• Review: 2019-06-19

Application Sponsors

NDA 207987

BELCHER

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRA-ARTERIAL	99% (1ML)	1	ABLYSINOL	ALCOHOL
002	SOLUTION;INTRA-ARTERIAL	99% (5ML)	1	ABLYSINOL	ALCOHOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2018-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

BPI LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207987
            [companyName] => BPI LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABLYSINOL","activeIngredients":"ALCOHOL","strength":"99% (1ML)","dosageForm":"SOLUTION;INTRA-ARTERIAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABLYSINOL","activeIngredients":"ALCOHOL","strength":"99% (5ML)","dosageForm":"SOLUTION;INTRA-ARTERIAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/21\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207987lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207987lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207987Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/207987Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-06-21
        )

)