ANDA 209533

CIPLA

FDA Drug Application

Application #209533

Application Sponsors

ANDA 209533

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION, METERED;TRANSDERMAL

30MG/1.5ML ACTUATION

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-01-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-05-10	STANDARD
REMS; REMS	SUPPL	4	AP	2019-06-04

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AT

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209533
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"30MG\/1.5ML ACTUATION","dosageForm":"SOLUTION, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/04\/2019","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-04
        )

)