ANDA 040430

BIONPHARMA INC

FDA Drug Application

Application #040430

Application Sponsors

ANDA 040430

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

ETHOSUXIMIDE

ETHOSUXIMIDE

FDA Submissions

	ORIG	1	AP	2002-10-28
LABELING; Labeling	SUPPL	4	AP	2008-03-03
LABELING; Labeling	SUPPL	5	AP	2009-12-10
LABELING; Labeling	SUPPL	6	AP	2011-12-27
REMS; REMS	SUPPL	7	AP	2012-10-19
LABELING; Labeling	SUPPL	8	AP	2014-01-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-04-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-02-16	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	17
SUPPL	8	Null	15
SUPPL	13	Null	7
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40430
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHOSUXIMIDE","activeIngredients":"ETHOSUXIMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ETHOSUXIMIDE","submission":"ETHOSUXIMIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)