ANDA 206118

TELIGENT PHARMA INC

FDA Drug Application

Application #206118

Application Sponsors

ANDA 206118

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT, AUGMENTED;TOPICAL

EQ 0.05% BASE

0

BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206118
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"OINTMENT, AUGMENTED;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-17
        )

)