MYLAN TECH VIATRIS FDA Approval ANDA 206497

ANDA 206497

MYLAN TECH VIATRIS

FDA Drug Application

Application #206497

Application Sponsors

ANDA 206497MYLAN TECH VIATRIS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL10MG/9HR (1.1MG/HR)0METHYLPHENIDATEMETHYLPHENIDATE
002FILM, EXTENDED RELEASE;TRANSDERMAL15MG/9HR (1.6MG/HR)0METHYLPHENIDATEMETHYLPHENIDATE
003FILM, EXTENDED RELEASE;TRANSDERMAL20MG/9HR (2.2MG/HR)0METHYLPHENIDATEMETHYLPHENIDATE
004FILM, EXTENDED RELEASE;TRANSDERMAL30MG/9HR (3.3MG/HR)0METHYLPHENIDATEMETHYLPHENIDATE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

MYLAN TECH VIATRIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206497
            [companyName] => MYLAN TECH VIATRIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"10MG\/9HR (1.1MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"15MG\/9HR (1.6MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"20MG\/9HR (2.2MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"30MG\/9HR (3.3MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPHENIDATE","submission":"METHYLPHENIDATE","actionType":"10MG\/9HR (1.1MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE","submission":"METHYLPHENIDATE","actionType":"15MG\/9HR (1.6MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE","submission":"METHYLPHENIDATE","actionType":"20MG\/9HR (2.2MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE","submission":"METHYLPHENIDATE","actionType":"30MG\/9HR (3.3MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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