Documents
Application Sponsors
NDA 020264 | BRISTOL MYERS SQUIBB | |
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEGACE | MEGESTROL ACETATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1993-09-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-07-29 | |
LABELING; Labeling | SUPPL | 3 | AP | 1996-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1997-08-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-03-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-06-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-07-27 | |
LABELING; Labeling | SUPPL | 9 | AP | 2002-04-09 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2003-05-01 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2012-04-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2016-05-02 | |
LABELING; Labeling | SUPPL | 21 | AP | 2019-07-18 | STANDARD |
Submissions Property Types
ORIG | 1 | Orphan | 5 |
SUPPL | 2 | Null | 14 |
SUPPL | 5 | Null | 14 |
SUPPL | 6 | Null | 14 |
SUPPL | 8 | Null | 14 |
SUPPL | 17 | Null | 15 |
SUPPL | 20 | Null | 14 |
SUPPL | 21 | Null | 7 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 20264
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"MEGACE","activeIngredients":"MEGESTROL ACETATE","strength":"40MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/18\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020264s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2012","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020264s017lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MEGACE","submission":"MEGESTROL ACETATE","actionType":"40MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-07-18
)
)