Documents
Application Sponsors
| NDA 022281 | BAYER HEALTHCARE LLC | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 20MG;1.1GM | 1 | ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE |
FDA Submissions
| TYPE 8; Type 8 - Partial Rx to OTC Switch | ORIG | 1 | AP | 2009-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2011-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2013-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2015-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2016-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-02-17 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2017-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-01-15 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2022-12-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 16 | Null | 6 |
CDER Filings
BAYER HEALTHCARE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 22281
[companyName] => BAYER HEALTHCARE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"ZEGERID OTC","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/15\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022281Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022281Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022281Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022281s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022281Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022281Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022281lbl.pdf\"}]","notes":""}]
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[supplements] =>
[actionDate] => 2019-01-15
)
)