ANDA 205646

HETERO LABS LTD V

FDA Drug Application

Application #205646

Application Sponsors

ANDA 205646

HETERO LABS LTD V

Marketing Status

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

Application Products

001	TABLET;ORAL	30MG	0	TOLVAPTAN	TOLVAPTAN
002	TABLET;ORAL	15MG	0	TOLVAPTAN	TOLVAPTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-07-16	STANDARD
UNKNOWN;	ORIG	2	TA	2021-07-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205646
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLVAPTAN","activeIngredients":"TOLVAPTAN","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOLVAPTAN","submission":"TOLVAPTAN","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)