NDA 003718

ROCHE

FDA Drug Application

Application #003718

Application Sponsors

NDA 003718

ROCHE

Marketing Status

• Discontinued: 004
• Discontinued: 006
• Discontinued: 008
• Discontinued: 010

Application Products

004	INJECTABLE;INJECTION	5MG/ML	0	SYNKAYVITE	MENADIOL SODIUM DIPHOSPHATE
006	INJECTABLE;INJECTION	10MG/ML	0	SYNKAYVITE	MENADIOL SODIUM DIPHOSPHATE
008	INJECTABLE;INJECTION	37.5MG/ML	0	SYNKAYVITE	MENADIOL SODIUM DIPHOSPHATE
010	TABLET;ORAL	5MG	0	SYNKAYVITE	MENADIOL SODIUM DIPHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1941-07-15	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	1996-03-27
LABELING; Labeling	SUPPL	7	AP	1996-03-27
LABELING; Labeling	SUPPL	8	AP	1987-09-08

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 3718
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SYNKAYVITE","activeIngredients":"MENADIOL SODIUM DIPHOSPHATE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SYNKAYVITE","activeIngredients":"MENADIOL SODIUM DIPHOSPHATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SYNKAYVITE","activeIngredients":"MENADIOL SODIUM DIPHOSPHATE","strength":"37.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SYNKAYVITE","activeIngredients":"MENADIOL SODIUM DIPHOSPHATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SYNKAYVITE","submission":"MENADIOL SODIUM DIPHOSPHATE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SYNKAYVITE","submission":"MENADIOL SODIUM DIPHOSPHATE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SYNKAYVITE","submission":"MENADIOL SODIUM DIPHOSPHATE","actionType":"37.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SYNKAYVITE","submission":"MENADIOL SODIUM DIPHOSPHATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)