Documents
Application Sponsors
| NDA 204399 | UPSHER SMITH LABS | |
Marketing Status
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 002 | GEL;TRANSDERMAL | 50MG/5GM PACKET | 0 | VOGELXO | TESTOSTERONE |
| 003 | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | 0 | VOGELXO | TESTOSTERONE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2014-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-05-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2016-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-05-10 | STANDARD |
| REMS; REMS | SUPPL | 11 | AP | 2019-05-30 | N/A |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-04-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 6 |
TE Codes
| 001 | Prescription | TBD |
| 002 | Prescription | AB2 |
| 003 | Prescription | BX |
CDER Filings
UPSHER SMITH LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 204399
[companyName] => UPSHER SMITH LABS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204399s012lbl.pdf#page=23"]
[products] => [{"drugName":"VOGELXO","activeIngredients":"TESTOSTERONE","strength":"50MG\/5GM PACKET","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VOGELXO","activeIngredients":"TESTOSTERONE","strength":"12.5MG\/1.25GM ACTUATION","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/30\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204399s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204399s010lbl.pdf\"}]","notes":""},{"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\\\/204399s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204399s002lbledt.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204399s002lbledt.pdf\"}]","notes":""},{"actionDate":"05\/11\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204399s002lbledt.pdf\"}]","notes":""},{"actionDate":"06\/04\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204399s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/04\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204399s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204399Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204399Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204399Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204399Orig1s000SumRedt.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/30\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204399s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204399Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"05\/30\/2019","submission":"SUPPL-11","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204399Orig1s011ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204399s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204399Orig1s010ltr.pdf\"}]","notes":">"},{"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\\\/204399s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204399Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/12\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/11\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204399s002lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204399Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-04-30
)
)