ANDA 078368

AM REGENT

FDA Drug Application

Application #078368

Documents

• Letter: 2008-01-09

Application Sponsors

ANDA 078368

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1.5GM/1.5ML (1GM/ML)

0

FOMEPIZOLE

FOMEPIZOLE

FDA Submissions

	ORIG	1	AP	2007-12-14
LABELING; Labeling	SUPPL	9	AP	2020-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	9	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78368
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOMEPIZOLE","activeIngredients":"FOMEPIZOLE","strength":"1.5GM\/1.5ML (1GM\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOMEPIZOLE","submission":"FOMEPIZOLE","actionType":"1.5GM\/1.5ML (1GM\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)