ANDA 078578

RUBICON

FDA Drug Application

Application #078578

Documents

• Other Important Information from FDA: 2008-11-25

Application Sponsors

ANDA 078578

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	200MG	0	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
003	TABLET;ORAL	400MG	0	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-11-06
LABELING; Labeling	SUPPL	2	AP	2014-12-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-12-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-07-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-07-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-11-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-11-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-11-21	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78578
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIODARONE HYDROCHLORIDE","activeIngredients":"AMIODARONE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIODARONE HYDROCHLORIDE","submission":"AMIODARONE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)