Documents
Application Sponsors
| NDA 021319 | GLAXOSMITHKLINE | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 0.5MG | 1 | AVODART | DUTASTERIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2001-11-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-10-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2004-08-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2004-09-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2005-12-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2008-06-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 15 | AP | 2008-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2010-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2010-09-09 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2011-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2011-06-09 | UNKNOWN |
| LABELING; Labeling | SUPPL | 27 | AP | 2012-06-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 28 | AP | 2013-04-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 29 | AP | 2013-04-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2013-09-10 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2020-01-30 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 7 |
TE Codes
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 21319
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"AVODART","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/30\/2020","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021319s032lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021319s028s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021319s028s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021319s027lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2011","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021319s023s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2011","submission":"SUPPL-23","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021319s023s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2010","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021319s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2010","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021319s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2008","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021319s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021319s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2004","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21319s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2004","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21319s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2002","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21-319s1lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21319lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AVODART","submission":"DUTASTERIDE","actionType":"0.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-01-30
)
)