ANDA 214376

AMTA

FDA Drug Application

Application #214376

Application Sponsors

ANDA 214376

AMTA

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

UNKNOWN;	ORIG	1	AP	2021-02-10	STANDARD
REMS; REMS	SUPPL	3	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214376
            [companyName] => AMTA
            [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":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)