Documents
Application Sponsors
| NDA 200534 | GENUS LIFESCIENCES | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 5MG | 1 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
| TYPE 7; Type 7 - Drug Already Marketed without Approved NDA | ORIG | 1 | AP | 2010-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2014-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-10-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2021-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 7 |
TE Codes
CDER Filings
GENUS LIFESCIENCES
cder:Array
(
[0] => Array
(
[ApplNo] => 200534
[companyName] => GENUS LIFESCIENCES
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/200534s010,200535s017lbl.pdf#page=67"]
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[supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/200534s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/200534Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"07\/21\/2021","submission":"SUPPL-10","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/200534s010,200535s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"10\/07\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200534s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200534Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200534s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200534Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-7","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200534s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200534Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200534s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200534Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/16\/2015","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-07-21
)
)