ANDA 040673

QUAGEN

FDA Drug Application

Application #040673

Documents

• Other Important Information from FDA: 2008-03-10

Application Sponsors

ANDA 040673

QUAGEN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	12.5MG	0	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2008-03-05

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

QUAGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40673
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)