NDA 021920

BIONPHARMA INC

FDA Drug Application

Application #021920

Documents

• Letter: 2006-03-01
• Letter: 2009-04-21
• Letter: 2009-07-17
• Letter: 2012-06-15
• Letter: 2013-04-03
• Label: 2006-02-28
• Other Important Information from FDA: 2006-03-02
• Letter: 2010-08-16
• Label: 2009-07-24
• Label: 2013-11-25
• Review: 2008-02-22
• Label: 2017-03-17
• Letter: 2017-03-20
• Label: 2018-12-04
• Letter: 2018-12-20
• Label: 2019-02-21
• Letter: 2019-02-22
• Letter: 2019-10-29
• Label: 2019-10-29
• Letter: 2019-12-11
• Label: 2019-12-11
• Letter: 2020-02-28
• Label: 2020-02-28
• Label: 2020-05-01
• Letter: 2020-05-01
• Letter: 2020-12-15
• Letter: 2021-12-16
• Label: 2021-12-16

Application Sponsors

NDA 021920

BIONPHARMA INC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG BASE

1

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-02-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2009-04-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2009-07-14	STANDARD
LABELING; Labeling	SUPPL	13	AP	2010-08-12	STANDARD
LABELING; Labeling	SUPPL	17	AP	2012-06-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2013-04-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-03-16	STANDARD
LABELING; Labeling	SUPPL	22	AP	2018-11-29	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-02-20	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-10-26	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-12-09	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-02-27	STANDARD
LABELING; Labeling	SUPPL	28	AP	2020-04-30	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-12-12	STANDARD
LABELING; Labeling	SUPPL	36	AP	2021-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	13	Null	7
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	19	Null	6
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	25	Null	31
SUPPL	26	Null	6
SUPPL	27	Null	6
SUPPL	28	Null	7
SUPPL	33	Null	7
SUPPL	36	Null	6

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21920
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/30\/2020","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021920Orig1s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021920Orig1s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/09\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021920Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021920Orig1s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021920Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021920Orig1s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021920Orig1s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021920Orig1s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021920s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021920s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-30
        )

)