ANDA 208560

LUPIN ATLANTIS

FDA Drug Application

Application #208560

Documents

• Letter: 2018-05-11

Application Sponsors

ANDA 208560

LUPIN ATLANTIS

Marketing Status

• Prescription: 001

Application Products

001

GEL, METERED;TRANSDERMAL

1.62% (20.25MG/1.25GM ACTUATION)

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN ATLANTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208560
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM ACTUATION)","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208560Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/03\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-03
        )

)