ANDA 040861

MIKART

FDA Drug Application

Application #040861

Documents

• Letter: 2010-06-08

Application Sponsors

ANDA 040861

MIKART

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	375MG	0	CHLORZOXAZONE	CHLORZOXAZONE
002	TABLET;ORAL	750MG	0	CHLORZOXAZONE	CHLORZOXAZONE

FDA Submissions

	ORIG	1	AP	2010-06-01
LABELING; Labeling	SUPPL	2	AP	2014-03-13

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	17

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40861
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORZOXAZONE","submission":"CHLORZOXAZONE","actionType":"375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CHLORZOXAZONE","submission":"CHLORZOXAZONE","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)