ANDA 075468

RUBICON

FDA Drug Application

Application #075468

Documents

• Letter: 2000-10-06

Application Sponsors

ANDA 075468

RUBICON

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	0.5MG	0	CLONAZEPAM	CLONAZEPAM
002	TABLET;ORAL	1MG	0	CLONAZEPAM	CLONAZEPAM
003	TABLET;ORAL	2MG	0	CLONAZEPAM	CLONAZEPAM

FDA Submissions

	ORIG	1	AP	2000-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-01-08
LABELING; Labeling	SUPPL	3	AP	2002-01-08
LABELING; Labeling	SUPPL	4	AP	2003-08-04
LABELING; Labeling	SUPPL	16	AP	2010-07-06
LABELING; Labeling	SUPPL	17	AP	2013-05-31	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-08-10	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-07-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75468
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)