BIONPHARMA INC FDA Approval NDA 021920

NDA 021920

BIONPHARMA INC

FDA Drug Application

Application #021920

Documents

Letter2006-03-01
Letter2009-04-21
Letter2009-07-17
Letter2012-06-15
Letter2013-04-03
Label2006-02-28
Other Important Information from FDA2006-03-02
Letter2010-08-16
Label2009-07-24
Label2013-11-25
Review2008-02-22
Label2017-03-17
Letter2017-03-20
Label2018-12-04
Letter2018-12-20
Label2019-02-21
Letter2019-02-22
Letter2019-10-29
Label2019-10-29
Letter2019-12-11
Label2019-12-11
Letter2020-02-28
Label2020-02-28
Label2020-05-01
Letter2020-05-01
Letter2020-12-15
Letter2021-12-16
Label2021-12-16

Application Sponsors

NDA 021920BIONPHARMA INC

Marketing Status

Over-the-counter001

Application Products

001CAPSULE;ORALEQ 200MG BASE1NAPROXEN SODIUMNAPROXEN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2006-02-17STANDARD
LABELING; LabelingSUPPL10AP2009-04-15STANDARD
LABELING; LabelingSUPPL11AP2009-07-14STANDARD
LABELING; LabelingSUPPL13AP2010-08-12STANDARD
LABELING; LabelingSUPPL17AP2012-06-13STANDARD
LABELING; LabelingSUPPL18AP2013-04-01STANDARD
LABELING; LabelingSUPPL19AP2017-03-16STANDARD
LABELING; LabelingSUPPL22AP2018-11-29STANDARD
LABELING; LabelingSUPPL23AP2019-02-20STANDARD
LABELING; LabelingSUPPL25AP2019-10-26STANDARD
LABELING; LabelingSUPPL26AP2019-12-09STANDARD
LABELING; LabelingSUPPL27AP2020-02-27STANDARD
LABELING; LabelingSUPPL28AP2020-04-30STANDARD
LABELING; LabelingSUPPL33AP2020-12-12STANDARD
LABELING; LabelingSUPPL36AP2021-12-13STANDARD

Submissions Property Types

ORIG1Null31
SUPPL13Null7
SUPPL17Null6
SUPPL18Null6
SUPPL19Null6
SUPPL22Null15
SUPPL23Null15
SUPPL25Null31
SUPPL26Null6
SUPPL27Null6
SUPPL28Null7
SUPPL33Null7
SUPPL36Null6

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
        )

)

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