ANI PHARMS INC FDA Approval NDA 202763

NDA 202763

ANI PHARMS INC

FDA Drug Application

Application #202763

Documents

Letter2012-02-17
Letter2014-06-23
Letter2015-05-13
Label2012-02-17
Other2012-03-06
Letter2014-07-24
Label2014-07-24
Label2014-06-23
Label2015-05-13
Review2012-04-17
Medication Guide2012-02-17
Summary Review2012-04-17
Letter2016-10-27
Label2016-11-01

Application Sponsors

NDA 202763ANI PHARMS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001GEL;TRANSDERMAL25MG/2.5GM PACKET0TESTOSTERONETESTOSTERONE
002GEL;TRANSDERMAL50MG/5GM PACKET0TESTOSTERONETESTOSTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2012-02-14STANDARD
LABELING; LabelingSUPPL2AP2014-06-19STANDARD
LABELING; LabelingSUPPL3AP2015-05-11STANDARD
LABELING; LabelingSUPPL4AP2016-10-25STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null6
SUPPL3Null7
SUPPL4Null15

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202763
            [companyName] => ANI PHARMS INC
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2012\/202763s000mg.pdf"]
            [products] => [{"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-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202763s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202763s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202763s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202763s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202763s001lbl.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\\\/202763s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202763s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/14\/2012","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\\\/2012\\\/202763s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202763s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202763Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202763Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/25\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202763s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202763Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/11\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202763s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202763Orig1s003ltr.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\\\/202763s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202763Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/23\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202763s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202763Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2016-10-25
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.