ANDA 207979

BIOCON LTD

FDA Drug Application

Application #207979

Application Sponsors

ANDA 207979

BIOCON LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 0.5MG BASE

0

FINGOLIMOD HYDROCHLORIDE

FINGOLIMOD HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-02-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BIOCON LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207979
            [companyName] => BIOCON LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD HYDROCHLORIDE","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-04
        )

)