Application Sponsors
ANDA 040479 | WATSON LABS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | SUPPOSITORY;RECTAL | 12.5MG | 0 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE |
002 | SUPPOSITORY;RECTAL | 25MG | 0 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE |
FDA Submissions
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 40479
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)