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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N207920-001NEXIUM 24HRESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N207920-00164288102019-11-03U-1785Drug product2015-12-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207920-0016428810*PED2020-05-03Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N207920-0016428810*PED2020-05-03Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207920-0016428810*PED2020-05-03Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N207920-00164288102019-11-03U-1785Drug product2015-12-183f01610625f2…
2019-12-14 00:12 UTC2019-12N207920-0016428810*PED2020-05-03Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N207920-00164288102019-11-03U-1785Drug product2015-12-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N207920-0016428810*PED2020-05-03Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N207920-00164288102019-11-03U-1785Drug product2015-12-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N207920-0016428810*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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC61f67858-ba2f-449b-8b30-c15cdaf492222025-01-09WarningsExact identifier
application applno (NDA): 207920
application number: NDA207920
ndc (product): 0573-2451

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 · 6 matching rows.

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