NDA 022032

DEXCEL PHARMA

FDA Drug Application

Application #022032

Documents

• Letter: 2007-07-05
• Letter: 2009-07-23
• Letter: 2011-07-05
• Letter: 2012-09-11
• Letter: 2012-10-30
• Letter: 2015-06-12
• Letter: 2016-02-11
• Label: 2009-07-24
• Label: 2014-01-15
• Label: 2015-06-19
• Review: 2009-05-28
• Letter: 2008-01-09
• Letter: 2009-04-07
• Letter: 2010-07-23
• Letter: 2012-04-11
• Letter: 2013-08-20
• Letter: 2015-03-10
• Label: 2013-09-19
• Label: 2015-03-12
• Label: 2016-02-11
• Summary Review: 2009-05-28
• Letter: 2017-11-06
• Label: 2017-11-13
• Label: 2017-11-14
• Letter: 2017-11-15
• Label: 2019-04-10
• Letter: 2019-04-10
• Letter: 2021-07-08
• Letter: 2022-10-03
• Label: 2022-10-05
• Letter: 2022-10-13
• Label: 2022-10-17

Application Sponsors

NDA 022032

DEXCEL PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

1

OMEPRAZOLE

OMEPRAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2007-12-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2009-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2009-09-21	N/A
LABELING; Labeling	SUPPL	8	AP	2010-07-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2011-06-27	UNKNOWN
LABELING; Labeling	SUPPL	16	AP	2012-04-09	STANDARD
LABELING; Labeling	SUPPL	19	AP	2012-09-10	STANDARD
LABELING; Labeling	SUPPL	20	AP	2012-10-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2013-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2013-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2015-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2016-01-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2015-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2015-06-01	STANDARD
LABELING; Labeling	SUPPL	29	AP	2015-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2016-02-08	STANDARD
LABELING; Labeling	SUPPL	32	AP	2016-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2016-12-01	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-10-30	STANDARD
LABELING; Labeling	SUPPL	38	AP	2017-11-13	STANDARD
LABELING; Labeling	SUPPL	41	AP	2019-04-08	STANDARD
LABELING; Labeling	SUPPL	46	AP	2021-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2021-10-21	N/A
LABELING; Labeling	SUPPL	57	AP	2022-09-30	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	8	Null	7
SUPPL	12	Null	6
SUPPL	16	Null	6
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	6
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	15
SUPPL	31	Null	0
SUPPL	32	Null	15
SUPPL	37	Null	15
SUPPL	38	Null	6
SUPPL	41	Null	7
SUPPL	46	Null	7
SUPPL	57	Null	7

CDER Filings

DEXCEL PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22032
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/08\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022032Orig1s041lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022032Orig1s038lbl.pdF\"}]","notes":""},{"actionDate":"10\/30\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022032Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022032Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022032Orig1s029lbll.pdf\"}]","notes":""},{"actionDate":"03\/06\/2015","submission":"SUPPL-24","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022032Orig1s024lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/16\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022032Orig1s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022032Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022032s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"20MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-04-08
        )

)