ANDA 075521

RUBICON

FDA Drug Application

Application #075521

Documents

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

Application Sponsors

ANDA 075521

RUBICON

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Prescription: 004
• Prescription: 005

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
004	TABLET;ORAL	7.5MG	0	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE
005	TABLET;ORAL	30MG	0	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-04-05
LABELING; Labeling	SUPPL	5	AP	2016-02-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-05-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-03-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	10	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75521
            [companyName] => RUBICON
            [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
        )

)