ANDA 203424

MYLAN

FDA Drug Application

Application #203424

Application Sponsors

ANDA 203424

MYLAN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	12.5MG;200MG;50MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
002	TABLET;ORAL	18.75MG;200MG;75MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
003	TABLET;ORAL	25MG;200MG;100MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
004	TABLET;ORAL	31.25MG;200MG;125MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
005	TABLET;ORAL	37.5MG;200MG;150MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
006	TABLET;ORAL	50MG;200MG;200MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-13

Submissions Property Types

ORIG

1

Null

17

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203424
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"12.5MG;200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"18.75MG;200MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"25MG;200MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"31.25MG;200MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"37.5MG;200MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"50MG;200MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-13
        )

)