ANDA 211255

ACTAVIS LABS FL INC

FDA Drug Application

Application #211255

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 211255

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

72MCG

0

LINACLOTIDE

LINACLOTIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211255
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINACLOTIDE","activeIngredients":"LINACLOTIDE","strength":"72MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-16
        )

)