ANDA 208891

MYLAN

FDA Drug Application

Application #208891

Documents

• Label: 2019-02-06
• Letter: 2019-02-21
• Review: 2022-06-28

Application Sponsors

ANDA 208891

MYLAN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	POWDER;INHALATION	0.1MG/INH;EQ 0.05MG BASE/INH	0	WIXELA INHUB	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
002	POWDER;INHALATION	0.25MG/INH;EQ 0.05MG BASE/INH	0	WIXELA INHUB	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
003	POWDER;INHALATION	0.5MG/INH;EQ 0.05MG BASE/INH	0	WIXELA INHUB	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	9	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208891
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"WIXELA INHUB","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.1MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WIXELA INHUB","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.25MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"WIXELA INHUB","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.5MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208891Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208891Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208891Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-01-30
        )

)