ANDA 200981

RUBICON

FDA Drug Application

Application #200981

Application Sponsors

ANDA 200981

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	25MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE
002	TABLET;ORAL	50MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE
003	TABLET;ORAL	100MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE
004	TABLET;ORAL	37.5MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE
005	TABLET;ORAL	75MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-10-28
LABELING; Labeling	SUPPL	7	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-05-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	7	Null	15
SUPPL	14	Null	7

TE Codes

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

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200981
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-03
        )

)