ANDA 201106

TARO

FDA Drug Application

Application #201106

Application Sponsors

ANDA 201106

TARO

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	CARBAMAZEPINE	CARBAMAZEPINE
002	CAPSULE, EXTENDED RELEASE;ORAL	200MG	0	CARBAMAZEPINE	CARBAMAZEPINE
003	CAPSULE, EXTENDED RELEASE;ORAL	300MG	0	CARBAMAZEPINE	CARBAMAZEPINE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-06-21

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201106
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"300MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-06-21
        )

)