ANDA 040479

WATSON LABS INC

FDA Drug Application

Application #040479

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

ORIG

1

AP

2003-06-24

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
        )

)