ANDA 211143

ALKEM LABS LTD

FDA Drug Application

Application #211143

Application Sponsors

ANDA 211143

ALKEM LABS LTD

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG TARTRATE	0	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG TARTRATE	0	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	0	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	0	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-11-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-08-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7

TE Codes

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

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211143
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 25MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 50MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 100MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 200MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)