FDA.reportPublic FDA data

Application 206877

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMTABLET, 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
A206877-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06

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 UTC2022-10A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06a50c72e98297…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON BASIC CARE OMEPRAZOLEOMEPRAZOLEAmazon.com Services LLC10efef7c-bdf4-36cf-e063-6394a90a8c0f2026-08-28WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
Acid ReducerOMEPRAZOLEINNOVUS PHARMACEUTICALS, INC.a4e92bd2-8f75-4acc-9b75-df8332bd4cc42026-06-04WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
Acid ReducerOMEPRAZOLERugby Laboratories33990795-e994-4307-a570-9e8e8b44c4732026-02-04WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 0536-1322
Acid ReducerOMEPRAZOLEFred's, Inc.7f00d0ed-4b7e-7011-e053-2a91aa0a24542024-06-27WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 55315-996
Acid ReducerOMEPRAZOLECVS Pharmacy, Inc.3349ee88-e53b-4586-8d28-20ecf8fcb1a52024-06-27WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 69842-941
Acid ReducerOMEPRAZOLEAurohealth LLC3eb70031-6439-44cf-8056-3e2e1e4a7fa92024-06-27WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 58602-826
Acid ReducerOMEPRAZOLEFamily Dollar Stores, LLC6d8daf78-1672-4bbf-a022-514bf0a5ac9a2024-06-17WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 55319-037
Acid ReducerOMEPRAZOLENORTHEAST PHARMA35ceccb5-dc3d-4ee1-bdac-35cb52c22f592024-06-15WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 80136-852
Acid ReducerOMEPRAZOLECardinal Health230e1aca-6644-4e6d-a6e1-9ba04cdcc8a82024-06-15WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 70000-0521
Acid ReducerOMEPRAZOLEWALGREEN CO.b9561780-e358-b610-e053-2a95a90af0202024-06-15WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 0363-1008
Acid ReducerOMEPRAZOLEKROGER COMPANYeb5d02a8-4112-2066-e053-2a95a90abba32024-06-15WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
Acid ReducerOMEPRAZOLEAurohealth LLCfde12bf8-3e3b-4813-a8c4-4385e7de82042024-06-14WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 58602-729
Acid ReducerOMEPRAZOLEWal-Mart Stores, Inc.1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c2024-06-14WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 49035-983
Acid ReducerOMEPRAZOLEWinco Foods, LLC.0cb2949a-baf2-4276-a27b-8f3cc4b9a6582024-06-14WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 67091-316
Acid ReducerOMEPRAZOLEDISCOUNT DRUG MARTff2c8446-9d8b-4300-b157-884b48e98bb72023-12-02WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 53943-016
Acid ReducerOMEPRAZOLEBest Choice43ea758b-6cea-44a2-b4d6-8f99211c88262023-12-02WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 63941-006
Acid ReducerOMEPRAZOLERELIABLE 1 LABORATORIES LLCf6b13640-6c71-4c3d-8eb5-c36fca201aee2023-12-02WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 69618-054
Acid ReducerOMEPRAZOLE7-Eleven61206416-e0c1-44d7-ad35-feb629361ba92023-12-02WarningsExact identifier
application applno (ANDA): 206877
application number: ANDA206877
ndc (product): 10202-722

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 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1008Acid ReducerOmeprazoleWALGREEN CO.ANDACurrent
0363-1008Acid ReducerOmeprazoleWALGREEN CO.ANDACurrent
0536-1322Acid ReducerOmeprazoleRugby LaboratoriesANDACurrent
0536-1322Acid ReducerOmeprazoleRugby LaboratoriesANDACurrent
10202-722Acid ReducerOmeprazole7-ElevenANDACurrent
10202-722Acid ReducerOmeprazole7-ElevenANDACurrent
10202-722Acid ReducerOmeprazole7-ElevenANDACurrent
10202-722Acid ReducerOmeprazole7-ElevenANDACurrent
10202-722Acid ReducerOmeprazole7-ElevenANDACurrent
37835-189Acid ReducerOmeprazoleBi-MartANDACurrent
37835-189Acid ReducerOmeprazoleBi-MartANDACurrent
37835-189Acid ReducerOmeprazoleBi-MartANDACurrent
49035-983Acid ReducerOmeprazoleWal-Mart Stores, Inc.ANDACurrent
49035-983Acid ReducerOmeprazoleWal-Mart Stores, Inc.ANDACurrent
49035-983Acid ReducerOmeprazoleWal-Mart Stores, Inc.ANDACurrent
49035-983Acid ReducerOmeprazoleWal-Mart Stores, Inc.ANDACurrent
53943-016Acid ReducerOmeprazoleDISCOUNT DRUG MARTANDACurrent
53943-016Acid ReducerOmeprazoleDISCOUNT DRUG MARTANDACurrent
53943-016Acid ReducerOmeprazoleDISCOUNT DRUG MARTANDACurrent
53943-016Acid ReducerOmeprazoleDISCOUNT DRUG MARTANDACurrent
55315-996Acid ReducerOmeprazoleFred's, Inc.ANDACurrent
55315-996Acid ReducerOmeprazoleFred's, Inc.ANDACurrent
55315-996Acid ReducerOmeprazoleFred's, Inc.ANDACurrent
55319-037Acid ReducerOmeprazoleFamily Dollar, Inc.ANDACurrent
55319-037Acid ReducerOmeprazoleFamily Dollar, Inc.ANDACurrent
55319-037Acid ReducerOmeprazoleFamily Dollar, Inc.ANDACurrent
55319-037Acid ReducerOmeprazoleFamily Dollar, Inc.ANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-729Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-826Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-826Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-826Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-850Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-850Acid ReducerOmeprazoleAurohealth LLCANDACurrent
58602-850Acid ReducerOmeprazoleAurohealth LLCANDACurrent
63941-006Acid ReducerOmeprazoleBest ChoiceANDACurrent
63941-006Acid ReducerOmeprazoleBest ChoiceANDACurrent
63941-006Acid ReducerOmeprazoleBest ChoiceANDACurrent
63941-006Acid ReducerOmeprazoleBest ChoiceANDACurrent
67091-316Acid ReducerOmeprazoleWinco Foods, LLC.ANDACurrent
67091-316Acid ReducerOmeprazoleWinco Foods, LLC.ANDACurrent
67091-316Acid ReducerOmeprazoleWinco Foods, LLC.ANDACurrent
69618-054Acid ReducerOmeprazoleRELIABLE 1 LABORATORIES LLCANDACurrent
69618-054Acid ReducerOmeprazoleRELIABLE 1 LABORATORIES LLCANDACurrent
69842-941Acid ReducerOmeprazoleCVS Pharmacy, Inc.ANDACurrent
69842-941Acid ReducerOmeprazoleCVS Pharmacy, Inc.ANDACurrent
69842-941Acid ReducerOmeprazoleCVS Pharmacy, Inc.ANDACurrent
70000-0521Acid ReducerOmeprazoleCardinal HealthANDACurrent
70000-0521Acid ReducerOmeprazoleCardinal HealthANDACurrent
70000-0521Acid ReducerOmeprazoleCardinal HealthANDACurrent
70000-0521Acid ReducerOmeprazoleCardinal HealthANDACurrent
80136-852Acid ReducerOmeprazoleNORTHEAST PHARMAANDACurrent
80136-852Acid ReducerOmeprazoleNORTHEAST PHARMAANDACurrent
80136-852Acid ReducerOmeprazoleNORTHEAST PHARMAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50994ORIG2018-01-08