BLA 125327

BTG INTERNATIONAL INC

FDA Drug Application

Application #125327

Documents

• Label: 2013-04-01
• Review: 2012-03-07
• Letter: 2012-01-20
• Letter: 2013-04-01
• Label: 2012-01-17
• Letter: 2019-08-14
• Label: 2019-08-15

Application Sponsors

BLA 125327

BTG INTERNATIONAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

1000 UNITS PER VIAL

0

VORAXAZE

GLUCARPIDASE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-01-17	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2013-03-29	STANDARD
LABELING; Labeling	SUPPL	64	AP	2019-08-13	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	64	Orphan	5

CDER Filings

BTG INTERNATIONAL INC

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(
    [0] => Array
        (
            [ApplNo] => 125327
            [companyName] => BTG INTERNATIONAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORAXAZE","activeIngredients":"GLUCARPIDASE","strength":"1000 UNITS PER VIAL","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/13\/2019","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125327s064lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2013","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125327s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125327lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125327lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125327s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/125327Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/13\/2019","submission":"SUPPL-64","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125327s064lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125327Orig1s064ltr.pdf\"}]","notes":">"},{"actionDate":"03\/29\/2013","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125327s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125327Orig1s020ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-08-13
        )

)