ANDA 208315

ALKEM LABS LTD

FDA Drug Application

Application #208315

Application Sponsors

ANDA 208315

ALKEM LABS LTD

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

2021-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208315
            [companyName] => ALKEM LABS LTD
            [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":"09\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-23
        )

)