ANDA 091558

APOTEX INC

FDA Drug Application

Application #091558

Documents

• Other: 2015-07-02

Application Sponsors

ANDA 091558

APOTEX INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	180MG	0	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID
002	TABLET, DELAYED RELEASE;ORAL	360MG	0	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID

FDA Submissions

	ORIG	1	AP	2012-08-21
	ORIG	2	AP	2014-08-19
LABELING; Labeling	SUPPL	3	AP	2014-06-26	STANDARD
REMS; REMS	SUPPL	6	AP	2015-11-13
LABELING; Labeling	SUPPL	8	AP	2019-12-31	STANDARD
REMS; REMS	SUPPL	12	AP	2021-01-15
REMS; REMS	SUPPL	16	AP	2021-04-21
REMS; REMS	SUPPL	18	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	15
SUPPL	3	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91558
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"180MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"360MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLIC ACID","submission":"MYCOPHENOLIC ACID","actionType":"180MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MYCOPHENOLIC ACID","submission":"MYCOPHENOLIC ACID","actionType":"360MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)