ANDA 078682

BIONPHARMA INC

FDA Drug Application

Application #078682

Documents

• Other Important Information from FDA: 2009-04-14
• Review: 2011-09-19
• Review: 2021-01-07
• Review: 2021-01-07
• Review: 2021-01-07

Application Sponsors

ANDA 078682

BIONPHARMA INC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG FREE ACID AND POTASSIUM SALT

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	2009-03-24
LABELING; Labeling	SUPPL	3	AP	2013-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2012-04-27
LABELING; Labeling	SUPPL	12	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2019-11-12	UNKNOWN
LABELING; Labeling	SUPPL	21	AP	2019-02-21	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	7	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7
SUPPL	21	Null	7

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78682
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"EQ 200MG FREE ACID AND POTASSIUM SALT","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)