GENUS LIFESCIENCES FDA Approval NDA 205103

NDA 205103

GENUS LIFESCIENCES

FDA Drug Application

Application #205103

Documents

Letter2016-09-19
Label2016-09-15
Label2017-10-05
Letter2017-10-06
Review2018-04-09
Label2018-06-12
Medication Guide2018-06-12
Letter2018-06-14
Label2020-11-30
Medication Guide2020-11-30
Letter2020-12-01
Letter2021-04-30
Label2021-05-03
Medication Guide2021-05-03
Letter2022-03-07
Label2022-03-09
Medication Guide2022-03-09

Application Sponsors

NDA 205103GENUS LIFESCIENCES

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORAL81MG;40MG1YOSPRALAASPIRIN; OMEPRAZOLE
002TABLET, DELAYED RELEASE;ORAL325MG;40MG1YOSPRALAASPIRIN; OMEPRAZOLE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2016-09-14STANDARD
LABELING; LabelingSUPPL4AP2018-06-07STANDARD
LABELING; LabelingSUPPL6AP2020-11-27STANDARD
LABELING; LabelingSUPPL7AP2021-04-28STANDARD
LABELING; LabelingSUPPL8AP2022-03-04STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null7
SUPPL6Null7
SUPPL7Null7
SUPPL8Null15

CDER Filings

GENUS LIFESCIENCES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205103
            [companyName] => GENUS LIFESCIENCES
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/205103s008lbl.pdf#page=29"]
            [products] => [{"drugName":"YOSPRALA","activeIngredients":"ASPIRIN; OMEPRAZOLE","strength":"81MG;40MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"YOSPRALA","activeIngredients":"ASPIRIN; OMEPRAZOLE","strength":"325MG;40MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/04\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205103s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205103s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205103s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205103s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205103s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205103s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205103s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205103s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205103s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205103s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205103s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205103Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/205103Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/04\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205103s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/205103Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205103s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/205103Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/27\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205103s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205103Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/07\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205103s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205103Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/04\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205103s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205103Origs001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-03-04
        )

)
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