ANDA 078950

BAXTER HLTHCARE CORP

FDA Drug Application

Application #078950

Application Sponsors

ANDA 078950

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

METOPROLOL TARTRATE

METOPROLOL TARTRATE

FDA Submissions

	ORIG	1	AP	2013-04-29
LABELING; Labeling	SUPPL	5	AP	2019-10-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78950
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)