ANDA 078492

WOCKHARDT BIO AG

FDA Drug Application

Application #078492

Application Sponsors

ANDA 078492

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.05MG/SPRAY

0

FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE

FDA Submissions

	ORIG	1	AP	2012-01-09
LABELING; Labeling	SUPPL	5	AP	2016-03-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78492
            [companyName] => WOCKHARDT BIO AG
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTICASONE PROPIONATE","activeIngredients":"FLUTICASONE PROPIONATE","strength":"0.05MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUTICASONE PROPIONATE","submission":"FLUTICASONE PROPIONATE","actionType":"0.05MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)