ANDA 201588

SANDOZ INC

FDA Drug Application

Application #201588

Documents

• Letter: 2011-10-26

Application Sponsors

ANDA 201588

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

10MG/VIAL

0

OLANZAPINE

OLANZAPINE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2011-10-24

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201588
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/24\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201588s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-10-24
        )

)