FDA.reportPublic FDA data

Application 022032

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLETABLET, DELAYED RELEASE;ORAL20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0915Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-0915Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-1723Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-1723Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-1803good sense omeprazole delayed releaseomeprazoleL. Perrigo CompanyNDACurrent
0113-7401Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7401Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7401Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7915Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7915Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0915omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0915omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0904-5834omeprazoleOmeprazoleMajor PharmaceuticalsNDACurrent
0904-5834omeprazoleOmeprazoleMajor PharmaceuticalsNDACurrent
10202-915seven select omeprazoleOmeprazole7-ElevenNDACurrent
10202-915seven select omeprazoleOmeprazole7-ElevenNDACurrent
11383-257OmeprazoleOmeprazoleWeeks & Leo Co., Inc.NDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-346up and up omeprazoleomeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11822-0453omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0453omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0915omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0915omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0915omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-1190omeprazoleomeprazoleRite Aid CorporationNDACurrent
21130-137Signature Care OmeprazoleOmeprazoleSafewayNDACurrent
21130-137Signature Care OmeprazoleOmeprazoleSafewayNDACurrent
21130-137Signature Care OmeprazoleOmeprazoleSafewayNDACurrent
21130-401signature care omeprazoleomeprazoleSafewayNDACurrent
21130-401signature care omeprazoleomeprazoleSafewayNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
36800-121TopCare Omeprazole delayed releaseOmeprazoleTopco Associates LLCNDACurrent
36800-121TopCare Omeprazole delayed releaseOmeprazoleTopco Associates LLCNDACurrent
36800-121TopCare Omeprazole delayed releaseOmeprazoleTopco Associates LLCNDACurrent
36800-915TopCare OmeprazoleOmeprazoleTopco Associates LLCNDACurrent
36800-915TopCare OmeprazoleOmeprazoleTopco Associates LLCNDACurrent
36800-915TopCare OmeprazoleOmeprazoleTopco Associates LLCNDACurrent
37012-401OmeprazoleOmeprazoleShopko Stores Operating Co., LLCNDACurrent
37012-401OmeprazoleOmeprazoleShopko Stores Operating Co., LLCNDACurrent
37012-915OmeprazoleOmeprazoleShopko Stores Operating Co., LLCNDACurrent
37205-837leader omeprazoleOmeprazoleCardinal HealthNDACurrent
37808-401omeprazoleOmeprazoleH E BNDACurrent
37808-401omeprazoleOmeprazoleH E BNDACurrent
37808-401omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
41163-614equaline omeprazole delayed releaseOmeprazoleSupervalu IncNDACurrent
41163-614equaline omeprazole delayed releaseOmeprazoleSupervalu IncNDACurrent
41163-915equaline omeprazoleOmeprazoleSupervalu IncNDACurrent
41163-915equaline omeprazoleOmeprazoleSupervalu IncNDACurrent
41190-915ShopRite OmeprazoleOmeprazoleWakefern Food CorporationNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83675SUPPL 2025-10-07
83665SUPPL 2025-10-06
81678SUPPL 2025-03-24
80200SUPPL 2024-11-12
80199SUPPL 2024-11-12
72399SUPPL2022-10-17
72315SUPPL2022-10-13
72252SUPPL2022-10-05
72212SUPPL2022-10-03
68033SUPPL2021-07-08
58277SUPPL2019-04-10
58273SUPPL2019-04-10
50429SUPPL2017-11-15
50411SUPPL2017-11-14
50362SUPPL2017-11-13
50295SUPPL2017-11-06
38112SUPPL2016-02-11
6733SUPPL2016-02-11
16804SUPPL2015-06-19
6732SUPPL2015-06-12
38111SUPPL2015-03-12
29114SUPPL2015-03-10
16803SUPPL2014-01-15
38110SUPPL2013-09-19
29113SUPPL2013-08-20
6731SUPPL2012-10-30
6730SUPPL2012-09-11
29112SUPPL2012-04-11
6729SUPPL2011-07-05
29111SUPPL2010-07-23
16802SUPPL2009-07-24
6728SUPPL2009-07-23
44669ORIG2009-05-28
21912ORIG2009-05-28
29110SUPPL2009-04-07
29109ORIG2008-01-09
6727ORIG2007-07-05