Documents
Application Sponsors
Marketing Status
Application Products
001 | VIAL | 150MG/VIAL | 0 | XOLAIR | OMALIZUMAB |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2003-06-20 | STANDARD |
S; Supplement | SUPPL | 5087 | AP | 2006-04-07 | |
LABELING; Labeling | SUPPL | 5102 | AP | 2007-07-02 | STANDARD |
LABELING; Labeling | SUPPL | 5154 | AP | 2009-07-24 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5161 | AP | 2014-09-26 | STANDARD |
LABELING; Labeling | SUPPL | 5165 | AP | 2010-07-30 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5166 | AP | 2010-01-04 | STANDARD |
LABELING; Labeling | SUPPL | 5180 | AP | 2010-12-21 | STANDARD |
LABELING; Labeling | SUPPL | 5191 | AP | 2011-12-22 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5211 | AP | 2014-03-21 | STANDARD |
LABELING; Labeling | SUPPL | 5224 | AP | 2015-12-03 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5225 | AP | 2016-07-06 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5231 | AP | 2018-09-28 | PRIORITY |
LABELING; Labeling | SUPPL | 5234 | AP | 2019-05-01 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5235 | AP | 2020-11-30 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5238 | AP | 2021-04-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5239 | AP | 2021-07-22 | STANDARD |
Submissions Property Types
SUPPL | 5087 | Null | 0 |
SUPPL | 5154 | Null | 7 |
SUPPL | 5161 | Null | 7 |
SUPPL | 5180 | Null | 7 |
SUPPL | 5191 | Null | 7 |
SUPPL | 5224 | Null | 6 |
SUPPL | 5225 | Null | 7 |
SUPPL | 5231 | Null | 6 |
SUPPL | 5234 | Null | 15 |
SUPPL | 5235 | Null | 6 |
SUPPL | 5238 | Null | 7 |
CDER Filings
GENENTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 103976
[companyName] => GENENTECH
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/103976s5234lbl.pdf#page=33"]
[products] => [{"drugName":"XOLAIR","activeIngredients":"OMALIZUMAB","strength":"150MG\/VIAL","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-5234","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103976s5234lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2018","submission":"SUPPL-5231","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103976s5231lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2016","submission":"SUPPL-5225","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103976s5225lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2015","submission":"SUPPL-5224","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103976s5224lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2014","submission":"SUPPL-5161","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5161lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2014","submission":"SUPPL-5211","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5211lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2007","submission":"SUPPL-5102","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103976s5102lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2006","submission":"SUPPL-5087","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103976s5097lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/omalgen062003LB.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/20\/2003","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/omalgen062003LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/omalgen062003L.htm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-5234","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103976s5234lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103976Orig1s5234ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2018","submission":"SUPPL-5231","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103976s5231lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103976Orig1s5231ltr.pdf\"}]","notes":">"},{"actionDate":"07\/06\/2016","submission":"SUPPL-5225","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103976s5225lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103976Orig1s5225ltr.pdf\"}]","notes":">"},{"actionDate":"12\/03\/2015","submission":"SUPPL-5224","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103976s5224lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103976Orig1s5224ltr.pdf\"}]","notes":">"},{"actionDate":"03\/21\/2014","submission":"SUPPL-5211","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5211lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103976Orig1s5211ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2011","submission":"SUPPL-5191","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/103976s5191ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2010","submission":"SUPPL-5180","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103976s5180ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2010","submission":"SUPPL-5166","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103976s5166ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2010","submission":"SUPPL-5165","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2014","submission":"SUPPL-5161","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103976s5161lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103976Orig1s5161ltr.pdf\"}]","notes":">"},{"actionDate":"07\/24\/2009","submission":"SUPPL-5154","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/02\/2007","submission":"SUPPL-5102","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103976s5102lbl.pdf\"}]","notes":">"},{"actionDate":"04\/07\/2006","submission":"SUPPL-5087","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103976s5097lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/103976s5097ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-05-01
)
)