ANDA 040851

MIKART

FDA Drug Application

Application #040851

Application Sponsors

ANDA 040851

MIKART

Marketing Status

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

Application Products

001	CAPSULE;ORAL	100MG	0	BENZONATATE	BENZONATATE
002	CAPSULE;ORAL	150MG	0	BENZONATATE	BENZONATATE
003	CAPSULE;ORAL	200MG	0	BENZONATATE	BENZONATATE

FDA Submissions

	ORIG	1	AP	2009-11-09
LABELING; Labeling	SUPPL	2	AP	2011-05-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40851
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)