NDA 006799

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #006799

Application Sponsors

NDA 006799

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 002
• Discontinued: 004
• Discontinued: 010

Application Products

002	INJECTABLE;INJECTION	0.1MG/ML	0	RUBRAMIN PC	CYANOCOBALAMIN
004	INJECTABLE;INJECTION	1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	RUBRAMIN PC	CYANOCOBALAMIN
010	INJECTABLE;INJECTION	1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	RUBRAMIN PC	CYANOCOBALAMIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1950-09-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-12-07
LABELING; Labeling	SUPPL	6	AP	1979-01-19
LABELING; Labeling	SUPPL	7	AP	1980-08-26
LABELING; Labeling	SUPPL	8	AP	1983-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-07-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	1984-07-09
LABELING; Labeling	SUPPL	11	AP	1984-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-10-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	2007-12-07
LABELING; Labeling	SUPPL	15	AP	1995-11-28	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6799
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUBRAMIN PC","activeIngredients":"CYANOCOBALAMIN","strength":"0.1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RUBRAMIN PC","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RUBRAMIN PC","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RUBRAMIN PC","submission":"CYANOCOBALAMIN","actionType":"0.1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RUBRAMIN PC","submission":"CYANOCOBALAMIN","actionType":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RUBRAMIN PC","submission":"CYANOCOBALAMIN","actionType":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)