FDA.reportPublic FDA data

Application 208025

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0116Good Sense LansoprazoleLansoprazoleL. Perrigo CompanyNDACurrent
0113-7116basic care lansoprazoleLansoprazoleL. Perrigo CompanyNDACurrent
0113-7116basic care lansoprazoleLansoprazoleL. Perrigo CompanyNDACurrent
0363-1419LansoprazoleLansoprazoleWalgreen CompanyNDACurrent
30142-192lansoprazolelansoprazoleKroger CompanyNDACurrent
30142-192lansoprazolelansoprazoleKroger CompanyNDACurrent
30142-192lansoprazolelansoprazoleKroger CompanyNDACurrent
36800-295topcare LansoprazolelansoprazoleTopco Associates LLCNDACurrent
49035-373equate lansoprazolelansoprazoleWal-Mart Stores IncNDACurrent
49035-373equate lansoprazolelansoprazoleWal-Mart Stores IncNDACurrent
49035-373equate lansoprazolelansoprazoleWal-Mart Stores IncNDACurrent
69842-507LansoprazoleLansoprazoleCVS PharmacyNDACurrent
69842-507LansoprazoleLansoprazoleCVS PharmacyNDACurrent
72288-829basic care lansoprazoleLansoprazoleAmazon.com Services LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85365SUPPL 2026-03-12
85364SUPPL 2026-03-12
72572SUPPL2022-11-07
72535SUPPL2022-11-02
65313SUPPL2020-11-25
65308SUPPL2020-11-25
58457SUPPL2019-04-29
58280SUPPL2019-04-10
50591SUPPL2017-12-04
50590SUPPL2017-12-04
50588SUPPL2017-12-04
50568SUPPL2017-12-01
50418SUPPL2017-11-15
48377SUPPL2017-05-15
48368SUPPL2017-05-12
47013SUPPL2017-01-30
47009SUPPL2017-01-30
45930ORIG2016-11-22
32877ORIG2016-06-13