ANDA 091496

PERRIGO ISRAEL

FDA Drug Application

Application #091496

Documents

• Letter: 2013-09-24

Application Sponsors

ANDA 091496

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;SUBLINGUAL

0.4MG/SPRAY

0

NITROGLYCERIN

NITROGLYCERIN

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-09-20

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91496
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.4MG\/SPRAY","dosageForm":"SPRAY, METERED;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROGLYCERIN","submission":"NITROGLYCERIN","actionType":"0.4MG\/SPRAY","submissionClassification":"SPRAY, METERED;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)