FDA.reportPublic FDA data

Application 210593

Type
ANDA
Sponsor
SPIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoNo

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
A210593-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20

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 UTC2022-10A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLERite Aidb1ba65d1-8f68-4bae-bb9d-776bba3483462022-03-03WarningsExact identifier
application applno (ANDA): 210593
application number: ANDA210593
ndc (product): 11822-0061
OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen Company537b9a46-ecc8-4537-9657-c9ff7821dd4b2021-12-03WarningsExact identifier
application applno (ANDA): 210593
application number: ANDA210593
ndc (product): 0363-9980
OmeprazoleOMEPRAZOLECVS Pharamacy, Inc0769e47f-f8f1-4b1c-a8cc-7c8385c740702021-04-16WarningsExact identifier
application applno (ANDA): 210593
application number: ANDA210593
ndc (product): 51316-061
OmeprazoleOMEPRAZOLE MAGNESIUMUP & UPac10cf46-1dcc-483a-83d6-2fcb9896cc192020-12-04WarningsExact identifier
application applno (ANDA): 210593
application number: ANDA210593
ndc (product): 11673-948
OmeprazoleOMEPRAZOLEMeijer Distribution Inc.8f5f9bbb-48d2-4fb1-81a2-3cbf070ed5732020-12-03WarningsExact identifier
application applno (ANDA): 210593
application number: ANDA210593
ndc (product): 79481-0061
omeprazoleOMEPRAZOLEINNOVUS PHARMACEUTICALS, INC.ce5c9fdc-0c50-4315-8f11-e00c9810abd02020-08-06WarningsExact identifier
application applno (ANDA): 210593
application number: ANDA210593
ndc (product): 57483-740

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9980OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen CompanyANDACurrent
0363-9980OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen CompanyANDACurrent
11673-948OmeprazoleOmeprazole MagnesiumUP & UPANDACurrent
11822-0061omeprazoleomeprazoleRite AidANDACurrent
11822-0061omeprazoleomeprazoleRite AidANDACurrent
46122-686OMEPRAZOLEOMEPRAZOLEAMERISOURCE BERGENANDACurrent
51316-061OmeprazoleOmeprazoleCVS Pharamacy, IncANDACurrent
51660-061OmeprazoleOmeprazoleOhm Laboratories Inc.ANDACurrent
51660-061OmeprazoleOmeprazoleOhm Laboratories Inc.ANDACurrent
57483-740omeprazoleomeprazoleINNOVUS PHARMACEUTICALS, INC.ANDACurrent
72559-010OmeprazoleOmeprazoleCuristANDACurrent
72559-010OmeprazoleOmeprazoleLittle Pharma, Inc.ANDACurrent
72559-010OmeprazoleOmeprazoleLittle Pharma, Inc.ANDACurrent
72559-010OmeprazoleOmeprazoleCuristANDACurrent
79481-0061OmeprazoleOmeprazoleMeijer Distribution Inc.ANDACurrent