FDA.reportPublic FDA data

Application 207920

Type
NDA
Sponsor
ASTRAZENECA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXIUM 24HRESOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-2451Nexium 24HResomeprazole magnesiumWyeth Consumer Healthcare LLCNDACurrent
0573-2451Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2451Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2451Nexium 24HResomeprazole magnesiumWyeth Consumer Healthcare LLCNDACurrent
0573-2451Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2451Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72056SUPPL2022-09-09
72021SUPPL2022-09-07
58248SUPPL2019-04-08
58247SUPPL2019-04-08
57218SUPPL2019-01-15
56573ORIG2018-11-27
56572ORIG2018-11-27
56571ORIG2018-11-27
56570ORIG2018-11-27
56569SUPPL2018-11-27
56568SUPPL2018-11-27
56567SUPPL2018-11-27