FDA.reportPublic FDA data

Application 209400

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL20MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0520good sense omeprazoleomeprazoleL. Perrigo CompanyNDACurrent
0113-0520good sense omeprazoleomeprazoleL. Perrigo CompanyNDACurrent
0113-7520basic care omeprazoleomeprazoleL. Perrigo CompanyNDACurrent
0113-7520basic care omeprazoleomeprazoleL. Perrigo CompanyNDACurrent
0363-1819omeprazoleomeprazoleWalgreen CompanyNDACurrent
0363-1819omeprazoleomeprazoleWalgreen CompanyNDACurrent
11673-212up and up omeprazoleomeprazoleTarget CorporationNDACurrent
11673-212up and up omeprazoleomeprazoleTarget CorporationNDACurrent
11673-212up and up omeprazoleomeprazoleTarget CorporationNDACurrent
11822-1040omeprazoleomeprazoleRite Aid CorporationNDACurrent
11822-1040omeprazoleomeprazoleRite Aid CorporationNDACurrent
21130-128Signature Care OmeprazoleomeprazoleSafewayNDACurrent
21130-128Signature Care OmeprazoleomeprazoleSafewayNDACurrent
21130-128Signature Care OmeprazoleomeprazoleSafewayNDACurrent
30142-394omeprazoleomeprazoleKroger CompanyNDACurrent
30142-394omeprazoleomeprazoleKroger CompanyNDACurrent
30142-394omeprazoleomeprazoleKroger CompanyNDACurrent
30142-394omeprazoleomeprazoleKroger CompanyNDACurrent
36800-601topcare omeprazoleomeprazoleTopco Associates LLCNDACurrent
36800-601topcare omeprazoleomeprazoleTopco Associates LLCNDACurrent
36800-601topcare omerprazoleomeprazoleTopco Associates LLCNDACurrent
37012-711omeprazoleomeprazoleShopko Stores Operating Co., LLCNDACurrent
37808-354omeprazoleomeprazoleH E BNDACurrent
37808-354omeprazoleomeprazoleH E BNDACurrent
41163-634equaline omeprazoleomeprazoleSupervalu IncNDACurrent
41163-634equaline omeprazoleomeprazoleSupervalu IncNDACurrent
41250-349OmeprazoleomeprazoleMeijer Distribution IncNDACurrent
41250-349OmeprazoleomeprazoleMeijer Distribution IncNDACurrent
41520-939careone omeprazoleomeprazoleAmerican Sales CompanyNDACurrent
41520-939careone omeprazoleomeprazoleAmerican Sales CompanyNDACurrent
41520-939careone omeprazoleomeprazoleAmerican Sales CompanyNDACurrent
46122-616good neighbor pharmacy omeprazoleomeprazoleAmerisource BergenNDACurrent
46122-616good neighbor pharmacy omeprazoleomeprazoleAmerisource BergenNDACurrent
49035-392Equate omeprazoleomeprazoleWal-Mart Stores IncNDACurrent
49035-392Equate omeprazoleomeprazoleWal-Mart Stores IncNDACurrent
55319-191family wellness omeprazoleomeprazoleFamily Dollar Services IncNDACurrent
55319-191family wellness omeprazoleomeprazoleFamily Dollar Services IncNDACurrent
55319-251Family Wellness Acid ReduceromeprazoleFamily Dollar Services IncNDACurrent
55910-713DG health omperazoleomeprazoleDolgencorp, LLCNDACurrent
55910-713DG health omperazoleomeprazoleDolgencorp, LLCNDACurrent
55910-713DG health omperazoleomeprazoleDolgencorp, LLCNDACurrent
55910-713DG health omperazoleomeprazoleDolgencorp, LLCNDACurrent
62011-0373Health Mart omeprazoleomeprazoleMckessonNDACurrent
62011-0373Health Mart omeprazoleomeprazoleStrategic Sourcing Services LLCNDACurrent
68196-303Members Mark OmeprazoleomeprazoleSam's West IncNDACurrent
68196-303Members Mark OmeprazoleomeprazoleSam's West IncNDACurrent
68391-103berkley and jensen omeprazoleomeprazoleBJWCNDACurrent
69842-791OmeprazoleomeprazoleCVS PharmacyNDACurrent
69842-791OmeprazoleomeprazoleCVS PharmacyNDACurrent
70000-0381Leader OmeprazoleomeprazoleCardinal Health 110, LLC. dba LeaderNDACurrent
70000-0381Leader OmeprazoleomeprazoleCardinal HealthNDACurrent
70000-0381Leader OmeprazoleomeprazoleCardinal HealthNDACurrent
72288-123Basic Care OmeprazoleomeprazoleAmazon.com Services LLCNDACurrent
72288-123Basic Care OmeprazoleomeprazoleAmazon.com Services LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85367SUPPL 2026-03-12
85366SUPPL 2026-03-12
72467SUPPL2022-10-26
72450SUPPL2022-10-24
68034SUPPL2021-07-08
65249SUPPL2020-11-17
62770SUPPL2020-04-30
62769SUPPL2020-04-30
57542SUPPL2019-02-13
57451SUPPL2019-02-06
55104SUPPL2018-08-03
54890SUPPL2018-07-16
54653SUPPL2018-06-21
54598SUPPL2018-06-14
53077ORIG2018-03-21
53019SUPPL2018-03-15
52785SUPPL2018-03-01
48948ORIG2017-07-11
48942ORIG2017-07-11