ANDA 204787

HETERO LABS LTD V

FDA Drug Application

Application #204787

Documents

• Letter: 2022-08-09

Application Sponsors

ANDA 204787

HETERO LABS LTD V

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	0	LACOSAMIDE	LACOSAMIDE
002	TABLET;ORAL	100MG	0	LACOSAMIDE	LACOSAMIDE
003	TABLET;ORAL	150MG	0	LACOSAMIDE	LACOSAMIDE
004	TABLET;ORAL	200MG	0	LACOSAMIDE	LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-17

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

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

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204787
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LACOSAMIDE","submission":"LACOSAMIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)