ANDA 211699

MYLAN PHARMS INC

FDA Drug Application

Application #211699

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 211699

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	UNKNOWN	UNKNOWN	0	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	BUDESONIDE;FORMOTEROL FUMARATE DIHYDRATE
002	AEROSOL, METERED;INHALATION	0.16MG/INH; 0.0045MG/INH	0	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	BUDESONIDE;FORMOTEROL FUMARATE DIHYDRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-05

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211699
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE","activeIngredients":"BUDESONIDE;FORMOTEROL FUMARATE DIHYDRATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-05
        )

)