NDA 021190

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021190

Documents

• Review: 2004-03-11

Application Sponsors

NDA 021190

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	CAPSULE;ORAL	5MG	0	BUSPAR	BUSPIRONE HYDROCHLORIDE
002	CAPSULE;ORAL	7.5MG	0	BUSPAR	BUSPIRONE HYDROCHLORIDE
003	CAPSULE;ORAL	10MG	0	BUSPAR	BUSPIRONE HYDROCHLORIDE
004	CAPSULE;ORAL	15MG	0	BUSPAR	BUSPIRONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2000-12-20

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21190
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUSPAR","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"7.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUSPAR","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)