ANDA 208061

LUPIN LTD

FDA Drug Application

Application #208061

Documents

• Letter: 2017-10-30

Application Sponsors

ANDA 208061

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION, METERED;TRANSDERMAL

30MG/1.5ML ACTUATION

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-23	STANDARD
REMS; REMS	SUPPL	2	AP	2019-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2020-01-29

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AT

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208061
            [companyName] => LUPIN LTD
            [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":"10\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208061Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/29\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/04\/2019","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-29
        )

)