GENENTECH FDA Approval BLA 103172

BLA 103172

GENENTECH

FDA Drug Application

Application #103172

Documents

Letter2004-03-10
Letter2015-02-17
Label2005-07-27
Label2015-03-02
Letter2004-03-12
Label2004-03-12
Label2004-03-10
Review2015-08-25
Label2017-07-03
Letter2017-07-05
Review2017-07-05
Letter2017-07-06
Letter2018-03-02
Letter2018-03-02
Label2018-03-15
Label2018-03-15
Letter2020-10-09
Letter2022-09-02
Label2022-09-02

Application Sponsors

BLA 103172GENENTECH

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001VIAL; SINGLE-USE100MG/VIAL0ACTIVASEALTEPLASE
002VIAL; SINGLE-USE50MG/VIAL0ACTIVASEALTEPLASE
003VIAL2MG/VIAL0CATHFLO ACTIVASEALTEPLASE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1987-11-13PRIORITY
EFFICACY; EfficacySUPPL1036AP1995-04-03PRIORITY
EFFICACY; EfficacySUPPL1055AP1996-06-18PRIORITY
EFFICACY; EfficacySUPPL5003AP2001-09-04STANDARD
S; SupplementSUPPL5009AP2002-05-15
EFFICACY; EfficacySUPPL5071AP2005-01-04STANDARD Label for CATHFLO ACTIVASE
LABELING; LabelingSUPPL5203AP2015-02-13STANDARD Label for ACTIVASE
LABELING; LabelingSUPPL5253AP2017-06-30STANDARD
LABELING; LabelingSUPPL5259AP2018-02-28STANDARD
LABELING; LabelingSUPPL5260AP2018-02-28STANDARD
LABELING; LabelingSUPPL5267TA2020-04-08STANDARD
LABELING; LabelingSUPPL5268AP2022-09-01STANDARD Label for ACTIVASE

Submissions Property Types

SUPPL5009Null0
SUPPL5203Null15
SUPPL5253Null15
SUPPL5259Null7
SUPPL5260Null7
SUPPL5267Null15
SUPPL5268Null7

CDER Filings

GENENTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103172
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACTIVASE","activeIngredients":"ALTEPLASE","strength":"100MG\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ACTIVASE","activeIngredients":"ALTEPLASE","strength":"50MG\/VIAL","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CATHFLO ACTIVASE","activeIngredients":"ALTEPLASE","strength":"2MG\/VIAL","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/28\/2018","submission":"SUPPL-5260","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103172s5260lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2018","submission":"SUPPL-5259","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103172s5259lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2017","submission":"SUPPL-5253","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103172s5253lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2015","submission":"SUPPL-5203","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103172s5203lbl.pdf\"}]","notes":"Label for ACTIVASE"},{"actionDate":"01\/04\/2005","submission":"SUPPL-5071","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103172s5071lbl.pdf\"}]","notes":"Label for CATHFLO ACTIVASE"},{"actionDate":"05\/15\/2002","submission":"SUPPL-5009","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/altegen051502LB.pdf\"}]","notes":""},{"actionDate":"09\/04\/2001","submission":"SUPPL-5003","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/altegen090401LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/13\/1987","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/08\/2020","submission":"SUPPL-5267","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103172Orig1s5267ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/28\/2018","submission":"SUPPL-5260","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103172s5260lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103172Orig1s5260ltr.pdf\"}]","notes":">"},{"actionDate":"02\/28\/2018","submission":"SUPPL-5259","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103172s5259lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103172Orig1s5259ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2017","submission":"SUPPL-5253","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103172s5253lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103172Orig1s5253ltr.pdf\"}]","notes":">"},{"actionDate":"02\/13\/2015","submission":"SUPPL-5203","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103172s5203lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103172Orig1s5203ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2015\\\/103172Orig1s5203.pdf\"}]","notes":"> Label for ACTIVASE"},{"actionDate":"01\/04\/2005","submission":"SUPPL-5071","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103172s5071lbl.pdf\"}]","notes":"> Label for CATHFLO ACTIVASE"},{"actionDate":"05\/15\/2002","submission":"SUPPL-5009","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/altegen051502LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/altegen051502L.htm\"}]","notes":">"},{"actionDate":"09\/04\/2001","submission":"SUPPL-5003","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/altegen090401LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2001\\\/altegen090401L.htm\"}]","notes":">"},{"actionDate":"06\/18\/1996","submission":"SUPPL-1055","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1996\\\/altegen061896L.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/96\\\/alteplase_toc.cfm\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/03\/1995","submission":"SUPPL-1036","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-08
        )

)
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