FDA.reportPublic FDA data

Application 204655

Type
NDA
Sponsor
ASTRAZENECA LP

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-2450Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumWyeth Consumer Healthcare LLCNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumWyeth Consumer Healthcare LLCNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumWyeth Consumer HealthcareNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2450Nexium 24HResomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumWyeth Consumer Healthcare LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumWyeth Consumer HealthcareNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumWyeth Consumer Healthcare LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
50090-1460Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1460Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1460Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1460Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1461Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1492Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1492Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1492Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent
50090-1492Nexium 24HResomeprazole magnesiumA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72057SUPPL2022-09-09
72020SUPPL2022-09-07
65524SUPPL2020-12-08
58246SUPPL2019-04-08
58245SUPPL2019-04-08
52422SUPPL2018-02-06
51906SUPPL2018-01-26
47105SUPPL2017-02-06
47104SUPPL2017-02-06
46953SUPPL2017-01-24
46854SUPPL2017-01-17
19583SUPPL2015-06-03
24477ORIG2014-12-09
22960ORIG2014-12-09
40408SUPPL2014-10-06
10376SUPPL2014-10-06
10375ORIG2014-04-02
40407ORIG2014-03-31