BLA 103909

GENENTECH

FDA Drug Application

Application #103909

Documents

• Letter: 2004-03-29
• Label: 2004-03-29
• Review: 2004-03-29
• Letter: 2018-03-02
• Label: 2018-03-15

Application Sponsors

BLA 103909

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

VIAL

50MG/VIAL

0

TNKASE

TENECTEPLASE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2000-06-02	STANDARD
LABELING; Labeling	SUPPL	5109	AP	2008-05-13	STANDARD
LABELING; Labeling	SUPPL	5187	AP	2018-02-28	STANDARD

Submissions Property Types

SUPPL

5187

Null

6

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103909
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"TNKASE","activeIngredients":"TENECTEPLASE","strength":"50MG\/VIAL","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/28\/2018","submission":"SUPPL-5187","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103909s5187lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20160803130402\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm093370.htm\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/02\/2000","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20160803130402\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm093370.htm\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2000\\\/tenegen060200L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20090119110643\\\/https:\\\/\\\/www.fda.gov\\\/cder\\\/biologics\\\/products\\\/tenegen060200.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/28\/2018","submission":"SUPPL-5187","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103909s5187lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103909Orig1s5187ltr.pdf\"}]","notes":">"},{"actionDate":"05\/13\/2008","submission":"SUPPL-5109","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-02-28
        )

)