ANDA 040062

MIKART

FDA Drug Application

Application #040062

Application Sponsors

ANDA 040062

MIKART

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG	0	METHAZOLAMIDE	METHAZOLAMIDE
002	TABLET;ORAL	50MG	0	METHAZOLAMIDE	METHAZOLAMIDE

FDA Submissions

	ORIG	1	AP	1994-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-08-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40062
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHAZOLAMIDE","activeIngredients":"METHAZOLAMIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHAZOLAMIDE","activeIngredients":"METHAZOLAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHAZOLAMIDE","submission":"METHAZOLAMIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHAZOLAMIDE","submission":"METHAZOLAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)