NDA 022283

BAYER HEALTHCARE LLC

FDA Drug Application

Application #022283

Documents

• Letter: 2013-06-28
• Letter: 2015-06-12
• Review: 2014-12-09
• Summary Review: 2014-12-09
• Label: 2013-09-24
• Label: 2015-06-18
• Letter: 2017-11-06
• Label: 2017-11-13
• Label: 2019-01-22
• Letter: 2019-02-13
• Letter: 2022-11-25
• Label: 2022-11-27

Application Sponsors

NDA 022283

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

FOR SUSPENSION;ORAL

20MG/PACKET;1.68GM/PACKET

1

ZEGERID OTC

OMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC Switch	ORIG	1	AP	2013-06-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-10-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-01-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-11-23	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22283
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEGERID OTC","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG\/PACKET;1.68GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/15\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022283Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022283Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022283Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022283Orig1s001bll.pdf\"}]","notes":""},{"actionDate":"06\/17\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022283Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZEGERID OTC","submission":"OMEPRAZOLE; SODIUM BICARBONATE","actionType":"20MG\/PACKET;1.68GM\/PACKET","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-15
        )

)