BLA 125422

THROMBOGENICS, INC

FDA Drug Application

Application #125422

Documents

• Letter: 2012-12-05
• Letter: 2016-03-29
• Letter: 2014-06-18
• Label: 2012-10-18
• Label: 2014-06-17
• Label: 2016-03-29
• Review: 2012-12-04
• Letter: 2017-02-23
• Label: 2017-02-23
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

BLA 125422

THROMBOGENICS, INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INTRAVITREAL

2.5MG/ML

0

JETREA

OCRIPLASMIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-10-17	PRIORITY
EFFICACY; Efficacy	SUPPL	25	AP	2014-06-13	PRIORITY
LABELING; Labeling	SUPPL	37	AP	2016-03-27	STANDARD
LABELING; Labeling	SUPPL	38	AP	2017-02-22	STANDARD

Submissions Property Types

SUPPL	37	Null	7
SUPPL	38	Null	7

CDER Filings

THROMBOGENICS, INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125422
            [companyName] => THROMBOGENICS, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"JETREA","activeIngredients":"OCRIPLASMIN","strength":"2.5MG\/ML","dosageForm":"INJECTABLE; INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/22\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125422s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2016","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125422s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2014","submission":"SUPPL-25","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125422s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125422s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125422s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125422Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/125422_jetrea_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/22\/2017","submission":"SUPPL-38","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125422s038lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125422Orig1s038ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2016","submission":"SUPPL-37","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125422s037lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125422Orig1s037ltr.pdf\"}]","notes":">"},{"actionDate":"06\/13\/2014","submission":"SUPPL-25","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125422s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125422Orig1s025ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-02-22
        )

)