ANDA 203005

ALKEM LABS LTD

FDA Drug Application

Application #203005

Documents

• Other: 2015-07-02

Application Sponsors

ANDA 203005

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/ML

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-11-14
LABELING; Labeling	SUPPL	2	AP	2015-11-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-01-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-01-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-01-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-25	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-03-08	STANDARD
REMS; REMS	SUPPL	13	AP	2021-01-15
REMS; REMS	SUPPL	16	AP	2021-04-21
REMS; REMS	SUPPL	17	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203005
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"200MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/14\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/15\/2021","submission":"SUPPL-13","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/25\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/11\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/11\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/06\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/13\/2015","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-15
        )

)