NDA 016119

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #016119

Application Sponsors

NDA 016119

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TESLAC

TESTOLACTONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1969-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-07-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1978-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1978-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1977-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1979-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1979-04-27	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16119
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESLAC","activeIngredients":"TESTOLACTONE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TESLAC","submission":"TESTOLACTONE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)