Documents
Application Sponsors
| BLA 125431 | GLAXOSMITHKLINE LLC | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 30MG | 0 | TANZEUM | ALBIGLUTIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2015-03-09 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 9 | AP | 2015-05-07 | STANDARD |
| REMS; REMS | SUPPL | 14 | AP | 2015-07-27 | N/A |
| LABELING; Labeling | SUPPL | 18 | AP | 2016-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2017-12-20 | STANDARD |
| REMS; REMS | SUPPL | 21 | AP | 2017-12-12 | N/A |
Submissions Property Types
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
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[ApplNo] => 125431
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/125431s019lbl.pdf#page=36"]
[products] => [{"drugName":"TANZEUM","activeIngredients":"ALBIGLUTIDE","strength":"30MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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[actionDate] => 2017-12-20
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)