ANDA 073484

BIONPHARMA INC

FDA Drug Application

Application #073484

Application Sponsors

ANDA 073484

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

	ORIG	1	AP	1993-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-10-08
LABELING; Labeling	SUPPL	13	AP	2006-12-17
LABELING; Labeling	SUPPL	14	AP	2007-09-23
LABELING; Labeling	SUPPL	17	AP	2008-04-01
LABELING; Labeling	SUPPL	18	AP	2010-01-12
LABELING; Labeling	SUPPL	20	AP	2011-01-25
LABELING; Labeling	SUPPL	22	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	23	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	24	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	25	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	26	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	27	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	28	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	30	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	31	AP	2019-12-09	STANDARD
LABELING; Labeling	SUPPL	32	AP	2019-12-09	STANDARD
LABELING; Labeling	SUPPL	34	AP	2019-12-09	STANDARD
LABELING; Labeling	SUPPL	37	AP	2019-12-09	STANDARD
LABELING; Labeling	SUPPL	38	AP	2019-12-09	STANDARD
LABELING; Labeling	SUPPL	39	AP	2022-01-14	STANDARD
LABELING; Labeling	SUPPL	42	AP	2022-01-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	18	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	15
SUPPL	30	Null	7
SUPPL	31	Null	15
SUPPL	32	Null	15
SUPPL	34	Null	15
SUPPL	37	Null	7
SUPPL	38	Null	7
SUPPL	39	Null	15
SUPPL	42	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73484
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)