ANDA 078084

BAXTER HLTHCARE CORP

FDA Drug Application

Application #078084

Application Sponsors

ANDA 078084

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/100ML

0

METRONIDAZOLE IN PLASTIC CONTAINER

METRONIDAZOLE

FDA Submissions

	ORIG	1	AP	2008-03-31
LABELING; Labeling	SUPPL	2	AP	2011-04-07
LABELING; Labeling	SUPPL	3	AP	2009-01-15
LABELING; Labeling	SUPPL	4	AP	2009-11-13
LABELING; Labeling	SUPPL	5	AP	2010-01-08
LABELING; Labeling	SUPPL	8	AP	2012-03-28
LABELING; Labeling	SUPPL	11	AP	2019-11-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-11-08	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	14	Null	7

TE Codes

001

Prescription

AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78084
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE IN PLASTIC CONTAINER","activeIngredients":"METRONIDAZOLE","strength":"500MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METRONIDAZOLE IN PLASTIC CONTAINER","submission":"METRONIDAZOLE","actionType":"500MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)