FDA.reportPublic FDA data

Application 021456

Type
NDA
Sponsor
EISAI MEDCL RES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACIPHEXRABEPRAZOLE SODIUMTablet, Delayed Release; Oral20MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC0863f340-4c7e-379a-e063-6394a90a758d2024-12-31Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC26f8c3bc-4402-e92c-e063-6294a90a9ad72024-11-15Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepack9ea2552c-873c-4ab2-84b0-dd54e84e4eee2024-08-21Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepack8d8c1a72-b4c4-4699-b9c3-3a39a9df44f22024-07-16Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP14412af6-e99c-4264-bc34-28a6f139f2522024-07-01Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepackb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf2024-05-20Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMGolden State Medical Supply, Inc.87231460-8b1e-b995-e053-2a91aa0a6c432024-04-16Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMAurobindo Pharma Limitedd11c3211-b4d4-4893-8c1c-b8fb6d0a0b892024-02-28Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMA-S Medication Solutionsbafff1ac-02fb-4726-b2d7-6e099ae981cb2023-12-11Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch Prepacke6350638-99b0-474d-be75-ae2a3e1af2cf2023-12-04Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMLannett Company, Inc.7f7d68f0-972b-4315-b712-0bb8a84c85cc2023-07-31Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMA-S Medication Solutions4ded337a-31b8-47c3-b5ab-33a785afb7d82023-02-06Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAsclemed USA, Inc.9881dbb2-1ce2-4737-989f-b26720791ca52022-07-07Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMProficient Rx LP0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d2022-04-01Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole sodiumRABEPRAZOLE SODIUMProficient Rx LPd1444508-fe40-4f68-8350-52f13399e38a2021-01-01Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMAsclemed USA, Inc.12eaf996-db61-41d6-82e1-fa61964356032020-06-26Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23663ORIG2011-12-20
36984ORIG2004-05-25
5442ORIG2004-05-25
21671ORIG2003-04-25