NDA 021359

ALLERGAN

FDA Drug Application

Application #021359

Documents

• Label: 2011-06-30
• Review: 2012-02-29
• Summary Review: 2012-02-29
• Letter: 2011-06-29

Application Sponsors

NDA 021359

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;INTRA-ANAL

0.4%

1

RECTIV

NITROGLYCERIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2011-06-21

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21359
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"RECTIV","activeIngredients":"NITROGLYCERIN","strength":"0.4%","dosageForm":"OINTMENT;INTRA-ANAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/21\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021359s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RECTIV","submission":"NITROGLYCERIN","actionType":"0.4%","submissionClassification":"OINTMENT;INTRA-ANAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-06-21
        )

)