ANDA 091161

APOTEX INC

FDA Drug Application

Application #091161

Documents

• Letter: 2016-03-24

Application Sponsors

ANDA 091161

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.05MG/SPRAY

0

MOMETASONE FUROATE

MOMETASONE FUROATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2016-03-22

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91161
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOMETASONE FUROATE","activeIngredients":"MOMETASONE FUROATE","strength":"0.05MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MOMETASONE FUROATE","submission":"MOMETASONE FUROATE","actionType":"0.05MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)