ANDA 090456

STRIDES PHARMA

FDA Drug Application

Application #090456

Documents

• Other: 2015-07-02

Application Sponsors

ANDA 090456

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

	ORIG	1	AP	2010-06-10
LABELING; Labeling	SUPPL	4	AP	2012-09-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2012-08-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-09-27	STANDARD
REMS; REMS	SUPPL	7	AP	2015-11-13
LABELING; Labeling	SUPPL	8	AP	2016-08-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-08-04	STANDARD
REMS; REMS	SUPPL	19	AP	2021-01-15
REMS; REMS	SUPPL	23	AP	2021-04-21
REMS; REMS	SUPPL	24	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	23	Null	7
SUPPL	24	Null	7

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90456
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)