ANDA 075572

NESHER PHARMS

FDA Drug Application

Application #075572

Documents

• Letter: 2003-04-10
• Letter: 2004-05-28

Application Sponsors

ANDA 075572

NESHER PHARMS

Marketing Status

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

Application Products

001	TABLET;ORAL	5MG	0	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE
003	TABLET;ORAL	15MG	0	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2002-02-27

Submissions Property Types

ORIG

1

Null

0

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75572
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUSPIRONE HYDROCHLORIDE","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUSPIRONE HYDROCHLORIDE","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUSPIRONE HYDROCHLORIDE","submission":"BUSPIRONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)