NDA 020120

LUPIN ATLANTIS

FDA Drug Application

Application #020120

Documents

• Letter: 2000-02-04
• Letter: 2009-01-09
• Label: 2000-02-04
• Label: 2009-01-07
• Review: 2002-11-20

Application Sponsors

NDA 020120

LUPIN ATLANTIS

Marketing Status

• Discontinued: 001

Application Products

001

SPRAY, METERED;NASAL

0.05MG/SPRAY

0

ALLERNAZE

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2009-01-07	N/A

Submissions Property Types

SUPPL

1

Null

0

CDER Filings

LUPIN ATLANTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20120
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALLERNAZE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.05MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/07\/2009","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020120s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2009","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020120s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20120lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALLERNAZE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.05MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-01-07
        )

)