Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INTRAMUSCULAR | 50MG/ML | 1 | FASLODEX | FULVESTRANT |
| 002 | SOLUTION;INTRAMUSCULAR | 125MG/2.5ML (50MG/ML) | 1 | FASLODEX | FULVESTRANT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2002-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2005-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2010-09-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2010-09-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2011-05-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2011-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2011-09-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2012-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2012-11-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2012-11-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2013-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2013-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2014-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2016-03-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2016-03-02 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2016-05-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2016-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2016-07-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2014-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2016-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2017-01-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 34 | AP | 2017-08-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2017-11-14 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2018-07-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2019-03-11 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 38 | AP | 2019-11-21 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2019-05-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2020-05-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 42 | AP | 2020-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2021-01-19 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 8 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 41 | Null | 15 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 44 | Null | 15 |
TE Codes
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 21344
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"FASLODEX","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021344s029lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2016","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021344s027lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2016","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021344s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2016","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021344s025lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2012","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021344s019s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2012","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021344s019s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021344s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2011","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021344s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2011","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021344s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2011","submission":"SUPPL-13","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021344s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2010","submission":"SUPPL-12","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021344s007s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021344s007s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2005","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021344s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2003","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21344se8-001_faslodex_lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21344lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"FASLODEX","submission":"FULVESTRANT","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-05-13
)
)