ANDA 078986

APOTEX INC

FDA Drug Application

Application #078986

Application Sponsors

ANDA 078986

APOTEX INC

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

	ORIG	1	AP	2011-11-25
LABELING; Labeling	SUPPL	2	AP	2014-03-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-11-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-11-08	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78986
            [companyName] => APOTEX INC
            [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":"CARBAMAZEPINE","submission":"CARBAMAZEPINE","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBAMAZEPINE","submission":"CARBAMAZEPINE","actionType":"200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBAMAZEPINE","submission":"CARBAMAZEPINE","actionType":"300MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)