NDA 020264

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020264

Documents

• Letter: 2002-04-09
• Letter: 2003-05-30
• Letter: 2012-04-11
• Label: 2012-04-09
• Review: 2011-12-14
• Label: 2019-07-19
• Letter: 2019-07-19

Application Sponsors

NDA 020264

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001

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40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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ACETATE","strength":"40MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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
        )

)