Application Sponsors
| NDA 011752 | BOEHRINGER INGELHEIM | |
Marketing Status
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 003 | TABLET, EXTENDED RELEASE;ORAL | 75MG | 0 | PRELUDIN | PHENMETRAZINE HYDROCHLORIDE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | 50MG | 0 | PRELUDIN | PHENMETRAZINE HYDROCHLORIDE |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 11752
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"PRELUDIN","activeIngredients":"PHENMETRAZINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRELUDIN","activeIngredients":"PHENMETRAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PRELUDIN","submission":"PHENMETRAZINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRELUDIN","submission":"PHENMETRAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)