ANDA 206497

MYLAN TECH VIATRIS

FDA Drug Application

Application #206497

Documents

• Letter: 2022-08-09

Application Sponsors

ANDA 206497

MYLAN TECH VIATRIS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	10MG/9HR (1.1MG/HR)	0	METHYLPHENIDATE	METHYLPHENIDATE
002	FILM, EXTENDED RELEASE;TRANSDERMAL	15MG/9HR (1.6MG/HR)	0	METHYLPHENIDATE	METHYLPHENIDATE
003	FILM, EXTENDED RELEASE;TRANSDERMAL	20MG/9HR (2.2MG/HR)	0	METHYLPHENIDATE	METHYLPHENIDATE
004	FILM, EXTENDED RELEASE;TRANSDERMAL	30MG/9HR (3.3MG/HR)	0	METHYLPHENIDATE	METHYLPHENIDATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

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
        )

)