ANDA 078165

RUBICON

FDA Drug Application

Application #078165

Documents

• Letter: 2007-09-07

Application Sponsors

ANDA 078165

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	3.125MG	0	CARVEDILOL	CARVEDILOL
002	TABLET;ORAL	6.25MG	0	CARVEDILOL	CARVEDILOL
003	TABLET;ORAL	12.5MG	0	CARVEDILOL	CARVEDILOL
004	TABLET;ORAL	25MG	0	CARVEDILOL	CARVEDILOL

FDA Submissions

	ORIG	1	AP	2007-09-05
LABELING; Labeling	SUPPL	5	AP	2010-02-16
LABELING; Labeling	SUPPL	7	AP	2014-09-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-04-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-03-11	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78165
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"3.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"3.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)