Application Sponsors
| NDA 011891 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 25MG/ML | 0 | DURABOLIN | NANDROLONE PHENPROPIONATE |
| 002 | INJECTABLE;INJECTION | 50MG/ML | 0 | DURABOLIN | NANDROLONE PHENPROPIONATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1959-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1985-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1987-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1987-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1990-05-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1994-02-18 | STANDARD |
Submissions Property Types
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 11891
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"DURABOLIN","activeIngredients":"NANDROLONE PHENPROPIONATE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DURABOLIN","activeIngredients":"NANDROLONE PHENPROPIONATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DURABOLIN","submission":"NANDROLONE PHENPROPIONATE","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DURABOLIN","submission":"NANDROLONE PHENPROPIONATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)