ANDA 209564

MYLAN

FDA Drug Application

Application #209564

Documents

• Letter: 2021-03-10

Application Sponsors

ANDA 209564

MYLAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	145MCG	0	LINACLOTIDE	LINACLOTIDE
002	CAPSULE;ORAL	290MCG	0	LINACLOTIDE	LINACLOTIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-02-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-05-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209564
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINACLOTIDE","activeIngredients":"LINACLOTIDE","strength":"145MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LINACLOTIDE","activeIngredients":"LINACLOTIDE","strength":"290MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-09
        )

)