PERRIGO ISRAEL FDA Approval NDA 203098

NDA 203098

PERRIGO ISRAEL

FDA Drug Application

Application #203098

Documents

Letter2013-02-04
Letter2015-05-13
Label2013-02-01
Label2014-06-23
Review2013-06-28
Other2015-07-07
Summary Review2013-06-28
Letter2014-06-23
Label2015-05-13
Letter2016-10-27
Label2016-11-01

Application Sponsors

NDA 203098PERRIGO ISRAEL

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001GEL, METERED;TRANSDERMAL12.5MG/1.25GM ACTUATION0TESTOSTERONETESTOSTERONE
002GEL;TRANSDERMAL25MG/2.5GM PACKET0TESTOSTERONETESTOSTERONE
003GEL;TRANSDERMAL50MG/5GM PACKET0TESTOSTERONETESTOSTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2013-01-31STANDARD
LABELING; LabelingSUPPL2AP2014-06-19901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2015-02-03STANDARD
LABELING; LabelingSUPPL6AP2015-05-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2016-02-26STANDARD
LABELING; LabelingSUPPL9AP2016-10-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL4Null0
SUPPL6Null15
SUPPL7Null0
SUPPL9Null7

CDER Filings

PERRIGO ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203098
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"12.5MG\/1.25GM ACTUATION","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"25MG\/2.5GM PACKET","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"50MG\/5GM PACKET","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/25\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203098s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203098s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203098s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203098s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203098s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203098s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/31\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203098s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203098Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203098Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203098Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/25\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203098s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203098Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/26\/2016","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/11\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203098s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203098Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"02\/03\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203098s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203098Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/01\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-10-25
        )

)
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