NDA 021472

BIONPHARMA INC

FDA Drug Application

Application #021472

Documents

• Letter: 2006-12-28
• Letter: 2010-05-03
• Label: 2004-02-03
• Label: 2006-03-14
• Letter: 2002-10-18
• Letter: 2004-02-02
• Letter: 2006-03-14
• Letter: 2006-01-19
• Letter: 2009-02-23
• Letter: 2009-04-21
• Review: 2004-11-22
• Label: 2017-03-17
• Letter: 2017-03-20
• Letter: 2021-10-22
• Label: 2022-01-05

Application Sponsors

NDA 021472

BIONPHARMA INC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

200MG

1

MIDOL LIQUID GELS

IBUPROFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-10-18	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2006-03-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-12-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-12-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2009-02-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2009-04-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2010-04-28	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2017-03-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	5	Null	0
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	6

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21472
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDOL LIQUID GELS","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/16\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021472Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021472Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2006","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021472s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21472slr001_ibuprofen_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MIDOL LIQUID GELS","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-16
        )

)