Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 200MG/ML | 0 | TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE |
FDA Submissions
| ORIG | 1 | AP | 2006-06-14 | |
LABELING; Labeling | SUPPL | 2 | AP | 2009-01-06 | |
LABELING; Labeling | SUPPL | 9 | AP | 2015-09-02 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-10-30 | STANDARD |
Submissions Property Types
SUPPL | 9 | Null | 15 |
SUPPL | 10 | Null | 15 |
TE Codes
CDER Filings
NEXUS PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 40575
[companyName] => NEXUS PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TESTOSTERONE ENANTHATE","activeIngredients":"TESTOSTERONE ENANTHATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TESTOSTERONE ENANTHATE","submission":"TESTOSTERONE ENANTHATE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)