PERRIGO ISRAEL FDA Approval ANDA 204268

ANDA 204268

PERRIGO ISRAEL

FDA Drug Application

Application #204268

Documents

Letter2015-08-06
Other2015-08-14

Application Sponsors

ANDA 204268PERRIGO ISRAEL

Marketing Status

Prescription001

Application Products

001GEL, METERED;TRANSDERMAL1.62% (20.25MG/1.25GM ACTUATION)0TESTOSTERONETESTOSTERONE

FDA Submissions

UNKNOWN; ORIG1AP2015-08-04
LABELING; LabelingSUPPL4AP2019-06-27STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null15

TE Codes

001PrescriptionAB

CDER Filings

PERRIGO ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204268
            [companyName] => PERRIGO ISRAEL
            [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":"08\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204268Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/27\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-27
        )

)

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