ANDA 201741

AM REGENT

FDA Drug Application

Application #201741

Application Sponsors

ANDA 201741

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

10MG/VIAL

0

OLANZAPINE

OLANZAPINE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-03-20
LABELING; Labeling	SUPPL	11	AP	2012-03-20

Submissions Property Types

ORIG	1	Null	15
SUPPL	11	Null	0

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201741
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/20\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/20\/2012","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2012-03-20
        )

)