Application Sponsors
| ANDA 083176 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | REMSED | PROMETHAZINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 25MG | 0 | REMSED | PROMETHAZINE HYDROCHLORIDE |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 83176
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"REMSED","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REMSED","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"REMSED","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"REMSED","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)