NDA 010349

BAXTER HLTHCARE CORP

FDA Drug Application

Application #010349

Application Sponsors

NDA 010349

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 006
• Discontinued: 008

Application Products

006	INJECTABLE;INJECTION	50MG/ML	0	SPARINE	PROMAZINE HYDROCHLORIDE
008	INJECTABLE;INJECTION	25MG/ML	0	SPARINE	PROMAZINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

1956-04-13

STANDARD

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10349
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPARINE","activeIngredients":"PROMAZINE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SPARINE","activeIngredients":"PROMAZINE HYDROCHLORIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SPARINE","submission":"PROMAZINE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SPARINE","submission":"PROMAZINE HYDROCHLORIDE","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)