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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204655-001NEXIUM 24HRESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N204655-00164288102019-11-03U-1874Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204655-00164288102019-11-03U-1509Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204655-0016428810*PED2020-05-03Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N204655-0016428810*PED2020-05-03Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204655-0016428810*PED2020-05-03Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N204655-00164288102019-11-03U-1874Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N204655-00164288102019-11-03U-1509Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N204655-0016428810*PED2020-05-03Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N204655-00164288102019-11-03U-1874Drug product2014-04-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N204655-00164288102019-11-03U-1509Drug product2014-04-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N204655-0016428810*PED2020-05-03Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N204655-00164288102019-11-03U-1874Drug product2014-04-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N204655-00164288102019-11-03U-1509Drug product2014-04-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N204655-0016428810*PED2020-05-03Pediatric extensionea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nexium 24HRESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsd56b330a-4355-4636-9d26-c592f67cea562024-05-14WarningsExact identifier
application applno (NDA): 204655
application number: NDA204655
ndc (product): 50090-1492
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC4513934d-0cf0-40fc-a348-b4e75a33b0942024-03-19WarningsExact identifier
application applno (NDA): 204655
application number: NDA204655
ndc (product): 0573-2452
ndc (product): 0573-2450

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

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 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
0573-2452Nexium 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
0573-2452Nexium 24HR ClearMinisesomeprazole magnesiumWyeth Consumer Healthcare 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
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