ANDA 040616

PLIVA

FDA Drug Application

Application #040616

Application Sponsors

ANDA 040616

PLIVA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009

Application Products

001	TABLET;ORAL	2MG	0	WARFARIN SODIUM	WARFARIN SODIUM
002	TABLET;ORAL	2.5MG	0	WARFARIN SODIUM	WARFARIN SODIUM
003	TABLET;ORAL	3MG	0	WARFARIN SODIUM	WARFARIN SODIUM
004	TABLET;ORAL	4MG	0	WARFARIN SODIUM	WARFARIN SODIUM
005	TABLET;ORAL	5MG	0	WARFARIN SODIUM	WARFARIN SODIUM
006	TABLET;ORAL	6MG	0	WARFARIN SODIUM	WARFARIN SODIUM
007	TABLET;ORAL	7.5MG	0	WARFARIN SODIUM	WARFARIN SODIUM
008	TABLET;ORAL	10MG	0	WARFARIN SODIUM	WARFARIN SODIUM
009	TABLET;ORAL	1MG	0	WARFARIN SODIUM	WARFARIN SODIUM

FDA Submissions

	ORIG	1	AP	2006-07-05
LABELING; Labeling	SUPPL	2	AP	2007-07-11
LABELING; Labeling	SUPPL	9	AP	2018-09-05	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-09-05	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-09-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2018-09-05	UNKNOWN

Submissions Property Types

SUPPL	9	Null	15
SUPPL	12	Null	7
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB
008	Prescription	AB
009	Prescription	AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40616
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)