ANDA 214289

TWI PHARMS

FDA Drug Application

Application #214289

Application Sponsors

ANDA 214289

TWI PHARMS

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

2021-11-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214289
            [companyName] => TWI PHARMS
            [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":"11\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-03
        )

)