Application Sponsors
| NDA 010347 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 004 |
Application Products
| 002 | SOLUTION;INTRAMUSCULAR | 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DELALUTIN | HYDROXYPROGESTERONE CAPROATE |
| 004 | SOLUTION;INTRAMUSCULAR | 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DELALUTIN | HYDROXYPROGESTERONE CAPROATE |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 10347
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"DELALUTIN","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"250MG\/ML (250MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DELALUTIN","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"125MG\/ML (125MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DELALUTIN","submission":"HYDROXYPROGESTERONE CAPROATE","actionType":"250MG\/ML (250MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DELALUTIN","submission":"HYDROXYPROGESTERONE CAPROATE","actionType":"125MG\/ML (125MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)